Recall Z-2466-2024 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Medical Systems, LLC
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
| Date | Aug 2, 2024 (initiated Jun 14, 2024) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant. |
| Root cause | Device Design |
| Action | GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value |
| Quantity | 123 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |