Recall Z-0595-2022 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
| Date | Dec 23, 2021 |
| Status | Open, Classified |
| Reason | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 12/23/2021 via FedEx explaining the safety issue and the actions to be taken by the customer/user. The actions say that the customer can continue to use the system as normal but they are to follow the instructions listed in the letter and to ensure the system is inspected either by GE Healthcare or the organization who installed their ventilation system to confirm it complies with the safety requirements for ventilation. The customer was requested to complete the workflow which was to be accessed through a QR code or link in the letter within the Medic |
| Quantity | 17,228 devices total in this field correction |
| Distribution | Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaidjan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and |
| FDA record | Open on fda.gov |