Achieva 3 — Class II medical device recall Z-0927-2019
Terminated recall by Philips Medical Systems Nederlands, reported 2019-03-06, distributed nationwide. There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by
| Recall number | Z-0927-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederlands, Best, Netherlands |
| Recall initiated | 2018-12-21 |
| Classified | 2019-02-22 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 11,226 total |
| Model numbers | 781477 |
Product
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
Reason for recall
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
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-0927-2019. 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.