NA 1.5T 4CH LARGE FLEX COILRecalls & reported problems
Ge Healthcare(Tianjin) Company Limited · 1.5T 4CH LARGE FLEX COIL · 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
- Jan 31, 2025Class IIOpen, Classified
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Z-1239-2025 · Root cause: Software design · Recall details · FDA record ↗
Other Coil, magnetic resonance, specialty devices
- NA SIGNA PremierGE Medical Systems, L.L.C. · Coil, magnetic resonance, specialty3 recalls0 reports
- NA SIGNA PremierGE Medical Systems, L.L.C. · Coil, magnetic resonance, specialty3 recalls0 reports
- MAGNETOM Skyra 10849580Siemens Healthcare GmbH · Coil, magnetic resonance, specialty2 recalls2 reports
- MAGNETOM Altea 11410371Siemens Healthcare GmbH · Coil, magnetic resonance, specialty1 recall2 reports
- MAGNETOM Spectra 10837643Siemens Shenzhen Magnetic Resonance Ltd. · Coil, magnetic resonance, specialty1 recall1 report
- MR Coils dS Breast 16ch 3.0TPhilips Medical Systems Nederland B.V. · Coil, Magnetic Resonance, Specialty1 recall0 reports
- Invivo 45353028072Philips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
- Philips dS Breast 7ch 3.0TPhilips Ds North America LLC · Coil, magnetic resonance, specialty1 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.
How reports and recalls are matched · Editorial policy · Report an error on this page