NA 6265300-20Recalls & reported problems
GE Medical Systems, L.L.C. · SIGNA Hero 3T Detachable Table Assembly · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jun 20, 2025Class IIOpen, 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.
Z-2308-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Other Table, radiologic devices
- ORT300 TableIMRIS Imaging, Inc. · Table, Radiologic2 recalls6 reports
- NA 6265300GE Medical Systems, L.L.C. · Table, radiologic2 recalls0 reports
- PST500 4080300Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall4 reports
- TS 7500 1730720Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall1 report
- TS 7500 1854086Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall0 reports
- TS 7500 1730732Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall0 reports
- TS 7000 1604786Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall0 reports
- TS 7500 1773204Baxter Medical Systems GmbH + Co. KG · Table, radiologic1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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