Device product
Mammotrak Diagnostic Coil 3.0T
Z-0543-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0543-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34.
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.