Ingenia 3 — Class II medical device recall Z-1849-2024
Ongoing recall by Philips North America Llc, reported 2024-05-29, distributed nationwide. The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may
| Recall number | Z-1849-2024 |
|---|---|
| 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 | 2024-05-03 |
| Classified | 2024-05-17 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HR, IT, JP, LB, LT, NL, NO, PL, RO, SE, SK, TH |
| Quantity | 350 units |
| UPC / GTIN / UDI-DI | 00884838068452, 00884838098312 |
| Serial numbers | 23032, 78000, 78003, 78004, 78005, 78007, 78008, 78009, 78010, 78011, 78012, 78013, 78014, 78015, 78016, 78017, 78018, 78019, 78021, 78022, 78023, 78025, 78026, 78027, 78028 and 324 more |
| Model numbers | 781271, 782105 |
Product
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
Reason for recall
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
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-1849-2024. 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.