Z-0131-2021Class II

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance -

Name: Z-0131-2021 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance -
Creator: GE Healthcare, LLC
Published: 2020-09-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-09-08 / Terminated

FDA source

GE Healthcare, LLC began a recall of Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent... on 2020-09-08. FDA classified it as Class II and gives the reason as "Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0131-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Posted: 2020-10-20
Terminated: 2021-04-28
Recalling firm: GE Healthcare
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.
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Reason for recall: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
FDA 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.
Product codes and lots: Model: 5726207-8 and 5741000-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0127-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0128-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0129-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0130-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0131-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20

Product code OUO

K163619Class IISigna Pet/mrGe Medical Systems, LLC / cleared 2017-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)