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.
FDA Recall Z-0131-2021 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeOUO
Date Initiated2020-09-08
Date Terminated2021-04-28
Reason for Recall
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Firm 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
Root Cause
Process change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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