Unnamed device
Model MP24 R03 · GE Medical Systems, L.L.C. · DI 00840682124591
OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (3)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2024-06-14 | Z-2466-2024 | Class II | Open, Classified | 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. | k number procode |
| 2021-12-23 | Z-0595-2022 | Class II | Open, Classified | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | k number procode |
| 2015-08-31 | Z-0260-2016 | Class II | Terminated | 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 from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2026-04 | 0 | 1 |
Regulatory clearances
- K142098 SESE 2014-11-24 (k number procode)
Predicate lineage
K142098 — cites (transitively): K081496 (d1), K132376 (d1), K133226 (d1), K123522 (d2), K103429 (d2), K123737 (d2), K123938 (d2), K081453 (d3), K082427 (d3), K113448 (d3), K121434 (d3), K091114 (d4), K103274 (d4), K053042 (d5) — cited as predicate by K150331, K161574, K163619, K183014
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Medical Systems, L.L.C.
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