Device product
ST SENSE Breast Dx Coil
Z-0548-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0548-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Potential safety issue where a patient may be harmed while preparing for or during a scan.