LOGIQ P9 R4.5Recalls & reported problems
GE Ultrasound Korea Ltd. · LOGIQ P9 R4.5 · Class 2
All models of LOGIQ (3)
Data updated Oct 16, 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.
2 other recalls cover devices cleared under the same FDA submission (K214039); they may or may not involve this specific model.
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 16, 2026.
Recalls naming this device
- Sep 18, 2025Open, Classified
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Z-0157-2026 · Root cause: Software design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K214039. One submission often covers many models, so check the product and lot details in each record.
- Z-0155-2026 · Sep 18, 2025 · Open, ClassifiedLOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Z-0156-2026 · Sep 18, 2025 · Open, ClassifiedLOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
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- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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