Ingenia 3 — Class II medical device recall Z-1848-2024
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-1848-2024 |
|---|---|
| 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 | 1,517 units |
| UPC / GTIN / UDI-DI | 00884838009813, 00884838055339, 00884838098299 |
| Serial numbers | 42001, 42002, 42003, 42004, 42005, 42006, 42007, 42008, 42009, 42010, 42011, 42012, 42013, 42014, 42015, 42017, 42018, 42019, 42021, 42025, 42026, 42027, 42028, 42030, 42031 and 475 more |
| Model numbers | 781342, 781377, 782103 |
Product
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
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-1848-2024. 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.