LOGIQ P10 series with software version R4 — Class II medical device recall Z-0155-2026
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 number | Z-0155-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-09-18 |
| Classified | 2025-10-15 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 65 units |
| UPC / GTIN / UDI-DI | 00195278464644 |
| Serial numbers | LPX440598, LPX440894, LPX440898, LPX440990, LPX440999, LPX441001, LPX441018, LPX441043, LPX441099, LPX441126, LPX441265, LPX441326, LPX441327, LPX441328, LPX441335, LPX441357, LPX441358, LPX441367, LPX441368, LPX441369, LPX441370, LPX441371, LPX441373, LPX441374, LPX441375 and 40 more |
| Model numbers | 5877534 |
Product
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
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-0155-2026. 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.