Intera 1 — Class II medical device recall Z-1934-2025
Ongoing recall by Philips North America, reported 2025-06-18, distributed nationwide. identified an issue where a component failure in the specific Gradient Coil type of affected systems can poten
| Recall number | Z-1934-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2025-05-29 |
| Classified | 2025-06-09 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, DE, EC, ES, IR, IT, JP, LB, MX, PL, PT |
| Quantity | 2 units |
| Serial numbers | 10403, 18969 |
Product
Intera 1.5T Omni/Stellar; Product Number: 781104;
Reason for recall
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
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-1934-2025. 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.