Achieva 1 — Class II medical device recall Z-0947-2024
Ongoing recall by Philips North America, reported 2024-02-07, distributed nationwide. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with pati
| Recall number | Z-0947-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2024-01-03 |
| Classified | 2024-02-01 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Reason classes | packaging, device malfunction |
| Model numbers | 781178, 781346 |
Product
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
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
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-0947-2024. 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.