Intera 1 — Class II medical device recall Z-1779-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-05-21, distributed nationwide. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with pati
| Recall number | Z-1779-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2025-03-24 |
| Classified | 2025-05-15 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Reason classes | packaging, device malfunction |
| Model numbers | 781170 |
Product
Intera 1.5T R11, Model Number: 781170;
Reason for recall
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Machine access
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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.