dS Breast 16ch 3 — Class II medical device recall Z-0538-2025
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-0538-2025 |
|---|---|
| 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 | 00459801729892, 00884838065840, 00884838086197, 00884838098381, 00884838118041 |
| Serial numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124 and 316 more |
| Model numbers | 453530280731, 459801290741, 459801290744, 459801729891, 459801729892 |
Product
dS Breast 16ch 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-0538-2025. 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.