Reported Oct 22, 2025 · Ongoing
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- Lot codes and dates
- Model Number 5877535 UDI-DI00195278464668
- Serial Numbers
LPZ490338LPZ490347LPZ490339LPZ490147LPZ490292LPZ490019LPZ490252LPZ490348LPZ490303LPZ490304LPZ490305LPZ490306LPZ490340LPZ490350LPZ490341LPZ440658LPZ440673LPZ440674LPZ490337LPZ440641LPZ440192LPZ440258LPZ440694LPZ440695LPZ440692LPZ440632LPZ440185LPZ440107LPZ440168LPZ440046LPZ440549
- Amount recalled
- 31 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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