LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values
GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states inaccurate measurements could lead to inappropriate clinical decisions, and no injuries are reported.
Plain-English summary
LOGIQ P10 R4.5 HD ultrasound systems with system software version R4.5.7, model number 5877535, are being recalled.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. The firm states this could potentially lead to inappropriate clinical decisions impacting overall care.
The recall covers 31 units carrying UDI-DI 00195278464668, with serial numbers including LPZ490338, LPZ490347, LPZ490339, LPZ490147 and LPZ490292. Distribution was nationwide in the United States and global. The FDA has classified the action as Class II.
Sites running the affected software version should follow GE's instructions and treat UGAP values from that version with caution.
The recalled product
- Product
- LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number 5877535 UDI-DI: 00195278464668
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Same hazard · software defect
See all →- HighBaxter Novum IQ Syringe Pump Recalled for Software Infusion Issue
FDA (Devices) · 2026-09-09
- HighBaxter Novum IQ Syringe Pump Software Issue Recall
FDA (Devices) · 2026-09-09
- HighMedos Velys Robotic-Assist Station Recalled for Software Movement Issue
FDA (Devices) · 2026-09-09
- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02