Home › Device types › OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
FDA product code OUO · Class 2 · Radiology
108
Registered devices
13
Adverse events
9
Recalls
15
510(k) clearances
Devices with this code
InfinityLock™ — QfixmMR Spine Matrix coil set — Siemens Healthcare GmbHEncompass™ — QfixAirShuttle Transfer Handle — QfixInfinityLock™ — QfixEncompass™ SRS Fibreplast™ System — QfixStradivarius™ — QfixZiFix™ — QfixEncompass™ SRS Fibreplast™ Anterior Mask — QfixmMR Head set — Siemens Healthcare GmbHApplicator Clamp Holder — Qfix3T Loop 11cm MR coil — Siemens Healthcare GmbHNA — GE Medical Systems, L.L.C.NA — GE Medical Systems, L.L.C.3T Loop 7 cm MR coil — Siemens Healthcare GmbHLeg Extension — QfixAlta — QfixBIOGRAPH One — Siemens Healthineers AGLumen AirShuttle — QfixAlta for HexaPOD — QfixFlex large 4 MR coil set 3T — Siemens Healthcare GmbHSymphony™ — Qfixspecial purpose coil 4 set — Siemens Shenzhen Magnetic Resonance Ltd.Symphony Locating Bar, PH Style — Qfix
Recent 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 esca |
| 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 S |
| 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 wh |
| 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 predicte |
| 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 i |
| 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. m |
| 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 |
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