Mammotrak Interventional Coil 1 — Class II medical device recall Z-0542-2025
Ongoing recall by Philips North America Llc, reported 2024-12-04, distributed nationwide. Potential safety issue where a patient may be harmed while preparing for or during a scan.
| Recall number | Z-0542-2025 |
|---|---|
| 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 | 2024-11-04 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 5,231 units |
| UPC / GTIN / UDI-DI | 00884838066779 |
| Serial numbers | 103, 124, 131, 134, 135, 138, 141, 143 |
| Model numbers | 453530228882 |
Product
Mammotrak Interventional Coil 1.5T
Reason for recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
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-0542-2025. 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.