Device product
SENSE Breast Coil 3.0T 7ch
Z-0546-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0546-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: REF: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52.
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.