Product Name: Ingenia Elition S — Class II medical device recall Z-1802-2025
Ongoing recall by Philips North America Llc, reported 2025-05-28, distributed nationwide. Potential for alignment errors in the cross reference line functionality when reviewing images generated with
| Recall number | Z-1802-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2025-05-13 |
| Classified | 2025-05-16 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HK, ID, IE, IL, IR, IS, IT, JO, JP, KE, KR, LB, LT, LV, MT, MX, MY, NL, NO, NZ, PH, PL, PT, QA, RO, RS, SE, SI, TH, TN, TR, TW, UA |
| UPC / GTIN / UDI-DI | 00884838088108, 00884838098329, 00884838108615 |
| Serial numbers | 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, 46203, 46206, 46207, 46208 and 40 more |
| Model numbers | 00884838088108, 00884838098329, 00884838108615, 781357, 782106, 782137 |
Product
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Reason for recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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-1802-2025. 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.