dS Breast 7ch 3 — Class II medical device recall Z-0540-2025
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-0540-2025 |
|---|---|
| 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 | 00453530280891, 00459801290712, 00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294 |
| Serial numbers | 100, 1000, 1001, 1002, 1003, 1004, 1006, 1007, 1008, 1009, 101, 1010, 1011, 1012, 1013, 1014, 102, 1022, 1027, 1028, 1029, 103, 1030, 1033, 1034 and 475 more |
| Model numbers | 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729912, 459801729913 |
Product
dS Breast 7ch 3.0T
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-0540-2025. 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.