FDA · Medical device recall

GE Healthcare MR superconducting magnets… and 31 more products

Feb. 16, 2022 Class II

Date: Feb. 16, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare, LLC
Reason: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Distribution pattern: Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaidjan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zambia, and Zimbabwe.

32 products in this recall

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0590-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0591-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0592-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0593-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0594-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0595-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0596-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0597-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0598-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0599-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0600-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0601-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0602-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0603-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0604-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0605-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0606-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0607-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0608-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0609-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0610-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0611-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0612-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0613-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0614-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0615-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0616-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0617-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0618-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0619-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0620-2022

GE Healthcare MR superconducting magnets…

Product: GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
Quantity: 17,228 devices total in this field correction
Codes and lots: All systems.
Recall started: Dec. 23, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process control
What the company told customers: The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medical Device Notification Acknowledgement Response Required form. It was to be returned no later than 30 days from receipt. The customer is also told it is important they continue to follow the guidelines outlined in the Safety chapter of their system Operator Manual, including ensuring a procedure is in place to evacuate the patient and personnel from the magnet room should a quench occur.
Recall number: Z-0621-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0590-2022, Z-0591-2022, Z-0592-2022, Z-0593-2022, Z-0594-2022, Z-0595-2022, Z-0596-2022, Z-0597-2022 and others. The agency record governs; check it and the company before acting.

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