FDA · Medical device recall

System… and 4 more products

Oct. 28, 2020 Class II

Date: Oct. 28, 2020
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: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

5 products in this recall

System…

Product: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Quantity: 30 devices total
Codes and lots: Model: 5741000 and 5741000-20
Recall started: Sept. 8, 2020
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process change control
What the company told customers: On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Recall number: Z-0127-2021

System…

Product: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Quantity: 30 devices total
Codes and lots: Model: 5741000-23 and 5396469
Recall started: Sept. 8, 2020
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process change control
What the company told customers: On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Recall number: Z-0128-2021

System…

Product: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Quantity: 30 Devices total
Codes and lots: Model: 5352293, 5726207-5, 5741000-25 and 5741000-29 .
Recall started: Sept. 8, 2020
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process change control
What the company told customers: On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Recall number: Z-0129-2021

System…

Product: System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Quantity: 30 devices Total
Codes and lots: Model: 5148810-3, 5741000-100, 5741000-26 and 5741000-27
Recall started: Sept. 8, 2020
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Process change control
What the company told customers: On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Recall number: Z-0130-2021

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance…

Product: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
Quantity: N/A
Codes and lots: Model: 5726207-8 and 5741000-28
Recall started: Sept. 8, 2020
Device type: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Root cause (FDA): Process change control
What the company told customers: On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Recall number: Z-0131-2021

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0127-2021, Z-0128-2021, Z-0129-2021, Z-0130-2021, Z-0131-2021. The agency record governs; check it and the company before acting.

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