dS Breast 7ch 1 — Class II medical device recall Z-0539-2025
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-0539-2025 |
|---|---|
| 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 | 00884838066847, 00884838086111 |
| Serial numbers | 100, 103, 104, 106, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082 and 475 more |
| Model numbers | 453530280881, 453530280882, 459801290431, 459801290432 |
Product
dS Breast 7ch 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-0539-2025. 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.