Unnamed device
Model SIGNA PET MR · GE Medical Systems, L.L.C. · DI 00840682105378
OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (7)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-06-20 | Z-2309-2025 | Class II | Open, Classified | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. | code info di |
| 2025-05-23 | Z-2133-2025 | Class II | Open, Classified | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. | code info di |
| 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 |
| 2021-06-04 | Z-2057-2021 | Class II | Open, Classified | 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 click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images. | k number procode |
| 2020-09-08 | Z-0131-2021 | Class II | Terminated | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | 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 (1)
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.
Injury: 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2026-04 | 1 | 1 |
Regulatory clearances
- K163619 SESE 2017-02-14 (k number procode)
- 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
K163619 — cites (transitively): K142098 (d1), K081496 (d2), K132376 (d2), K133226 (d2), K123522 (d3), K103429 (d3), K123737 (d3), K123938 (d3), K081453 (d4), K082427 (d4), K113448 (d4), K121434 (d4), K091114 (d5), K103274 (d5), K053042 (d6) — cited as predicate by K213709
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Medical Systems, L.L.C.
Nothing in the loaded window.