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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Model: 5726207-8 and 5741000-28
Products Sold
Model: 5726207-8 and 5741000-28
GE Healthcare, LLC is recalling Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product due to Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026