FDA Medical Device Recalls (openFDA)
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 number
- Z-0131-2021
- Recalling firm
- GE Healthcare, LLC
- 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.
- Status
- Terminated
- Initiated
- 2020-09-08
- Posted
- not on file
- Terminated
- 2021-04-28
- 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
- not on file
- 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.
- Lot, serial or model codes
- Model: 5726207-8 and 5741000-28
- 510(k) numbers
- ["K163619"]
- PMA numbers
- not on file
- Product code
- OUO
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28