FDA Device recall Z-0547-2025
ST SENSE Breast Coil
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of ST SENSE Breast Coil 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-0547-2025 |
| 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
ST SENSE Breast Coil
Reason
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Identifiers
| code_info | REF: 453530054571; UDI-DI: 00884838066625; Serial No. 36577, 36597, 36664, 36706, 36540, 36604, 36590, 36670, 36671, 36…REF: 453530054571; UDI-DI: 00884838066625; Serial No. 36577, 36597, 36664, 36706, 36540, 36604, 36590, 36670, 36671, 36704, 36710, 36712, 36524, 36555, 36519, 36521, 36570, 36573, 36582, 36580, 36581, 36603, 36619, 36663, 36680, 36711, 36548, 36576, 36589, 36606, 36523, 36567, 36572, 36601, 36639, 36661, 36536, 36588, 36635, 36631, 36668, 36613, 36677, 36530, 36556, 36661, 36575, 36592, 36632, 36657, 36669, 36602, 36674, 36703, 36534, 36551, 36541, 36549, 36547, 36525, 36526, 36528, 36574, 36571, 36595, 36614, 36605, 36600, 36636, 36634, 36662, 36641. |
|---|
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-0547-2025%22
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