FDA Device recall Z-0543-2025
Mammotrak Diagnostic Coil 3.0T
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Mammotrak Diagnostic Coil 3.0T by Philips North America, citing potential safety issue where a patient may be harmed while preparing for or during a scan.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-04 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Mammotrak Diagnostic Coil 3.0T
Reason
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Identifiers
| code_info | REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.