FDA · Medical device recall

SIGNA Premier nuclear magnetic resonance imaging system and 9 more products

Oct. 27, 2021 Class II

Date: Oct. 27, 2021
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: Terminated
Filed by: GE Healthcare, LLC
Reason: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Distribution pattern: Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

10 products in this recall

SIGNA Premier nuclear magnetic resonance imaging system

Product: SIGNA Premier nuclear magnetic resonance imaging system
Quantity: 11 devices
Codes and lots: Software version RX29.1 and RX27.3 (China only)
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0132-2022

SIGNA Architect nuclear magnetic resonance imaging system

Product: SIGNA Architect nuclear magnetic resonance imaging system
Quantity: 2 devices
Codes and lots: Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only)
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0133-2022

SIGNA Pioneer nuclear magnetic resonance imaging system

Product: SIGNA Pioneer nuclear magnetic resonance imaging system
Quantity: 5 devices
Codes and lots: Software version PX29.1; and PX25.4 (T), PX28.3 (China only)
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0134-2022

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

Product: Discovery MR750w 3.0T nuclear magnetic resonance imaging system
Quantity: 13 devices
Codes and lots: Software version DV29.1
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0135-2022

Discovery MR750 3.0T nuclear magnetic resonance imaging system

Product: Discovery MR750 3.0T nuclear magnetic resonance imaging system
Quantity: 5 devices
Codes and lots: Software version DV29.1
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0136-2022

SIGNA Creator…

Product: SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Quantity: 6 devices
Codes and lots: Software version DV29.1
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0137-2022

SIGNA Voyager nuclear magnetic resonance imaging system

Product: SIGNA Voyager nuclear magnetic resonance imaging system
Quantity: 15 devices
Codes and lots: Software version VX29.1; and PX26.4 (China only)
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0138-2022

SIGNA Artist nuclear magnetic resonance imaging system

Product: SIGNA Artist nuclear magnetic resonance imaging system
Quantity: 18 devices
Codes and lots: Software version DV29.1
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0139-2022

Optima MR450w 1.5T nuclear magnetic resonance imaging system

Product: Optima MR450w 1.5T nuclear magnetic resonance imaging system
Quantity: 13 devices
Codes and lots: Software version DV29.1
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0140-2022

1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

Product: 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Quantity: 3 devices
Codes and lots: Software version HD29.1; and HD16.2 (China only)
Recall started: Aug. 26, 2021
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Recall number: Z-0141-2022

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0132-2022, Z-0133-2022, Z-0134-2022, Z-0135-2022, Z-0136-2022, Z-0137-2022, Z-0138-2022, Z-0139-2022 and others. The agency record governs; check it and the company before acting.

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