Lumify Diagnostic Ultrasound System models : 795005 — Class II medical device recall Z-0883-2026
Ongoing recall by Philips Ultrasound, LLC, reported 2025-12-10, distributed nationwide. Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live i
| Recall number | Z-0883-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, LLC, Bothell, WA, United States |
| Recall initiated | 2025-10-31 |
| Classified | 2025-12-04 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CL, CO, CR, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HN, HU, ID, IL, IN, IS, IT, JO, KR, KW, LU, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, SE, SG, SK, SV, TH, TN, TT, TW, UY, VN, ZA |
| Quantity | 4,819 systems |
| UPC / GTIN / UDI-DI | 00884838064713, 00884838108455, 00884838120266 |
| Serial numbers | US122L0037, US122L0038, US122L0039, US122L0040, US122L0151, US122L0152, US122L0153, US122L0415, US122L0416, US122L0417, US122L0522, US122L0523, US122L0602, US122L0603, US122L0996, US122L1048, US122L1174, US122L1175, US122L1176, US122L1177, US122L1178, US122L1179, US122L1180, US122L1181, US122L1182 and 475 more |
| Model numbers | 795005, 795161, 989605449841 |
Product
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Reason for recall
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
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-0883-2026. 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.