Ingenia 1 — Class II medical device recall Z-1829-2024
Ongoing recall by Philips North America Llc, reported 2024-05-22, distributed nationwide. Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting whi
| Recall number | Z-1829-2024 |
|---|---|
| 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 | 2024-04-22 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, FI, FR, GB, HR, IT, LB, NL, NO, SE, TH |
| Quantity | 32 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838099722 |
| Serial numbers | 41017, 41024, 41025, 41041, 41047, 41051, 41080, 41089, 41130, 41143, 41144, 41189, 41196, 41226, 41235, 41286, 41287, 41344, 41367, 41413, 41432, 41433, 41497, 41520, 70093 and 7 more |
| Model numbers | 782116 |
Product
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Reason for recall
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
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-1829-2024. 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.