Data Foundry

Medical device recalls 2025

LOGIQ P10 R4 — Class II medical device recall Z-0156-2026

Ongoing recall by GE Medical Systems, LLC, reported 2025-10-22, distributed nationwide. The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing

Recall numberZ-0156-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems, LLC, Waukesha, WI, United States
Recall initiated2025-09-18
Classified2025-10-15
Reported by FDA2025-10-22
DistributedNationwide (US)
Quantity31 units
UPC / GTIN / UDI-DI00195278464668
Serial numbersLPZ440046, LPZ440107, LPZ440168, LPZ440185, LPZ440192, LPZ440258, LPZ440549, LPZ440632, LPZ440641, LPZ440658, LPZ440673, LPZ440674, LPZ440692, LPZ440694, LPZ440695, LPZ490019, LPZ490147, LPZ490252, LPZ490292, LPZ490303, LPZ490304, LPZ490305, LPZ490306, LPZ490337, LPZ490338 and 6 more
Model numbers5877535

Product

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0156-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.