Recall Z-0131-2021 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare, LLC
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.
| 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 |
| 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 |
510(k) clearances named in this recall
| K163619 | SIGNA PET/MR Ge Medical Systems, LLC, Feb 14, 2017 |