Recall Z-0128-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
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.
| Date | Sep 8, 2020 |
| Status | Terminated |
| Reason | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| Root cause | Process change control |
| Action | 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 |
| Quantity | 30 devices total |
| Distribution | 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. |
| FDA record | Open on fda.gov |