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GE Medical Systems, L.L.C. · Model MP24 R03 · UDI-DI 00840682124591
OUO
Prescription
1
510(k) clearances
13
Adverse events
9
Recalls
11
Facilities
Description
MR Applications Software for MP24 R03
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-28 | Siemens Medical Solutions USA, Inc | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the desig |
| 2024-06-14 | GE Medical Systems, LLC | 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 foll |
| 2021-12-23 | GE Healthcare, LLC | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. |
| 2021-06-04 | GE Healthcare, LLC | GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to clic |
| 2020-09-08 | GE Healthcare, LLC | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. |
| 2015-08-31 | GE Healthcare | When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value fro |
| 2015-07-23 | Philips Medical Systems (Cleveland) Inc | Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and befo |
| 2015-03-06 | Philips Medical Systems (Cleveland) Inc | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery |
| 2012-04-13 | Philips Medical Systems (Cleveland) Inc | Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm sta |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.