—#183737

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.

FDA product code: OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163619
Affected lot / code info: Model: 5726207-8 and 5741000-28

Why it was recalled

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Root cause (FDA determination)

Process change control

Action the firm took

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

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2020-09-08
Terminated: 2021-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.