Device product
Mammotrak Interventional Coil 3.0T
Z-0544-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0544-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: REF: 453530228891; UDI-DI: 00884838065857; Serial No. 73, 96, 58, 95, 119, 26, 16, 56, 94, 38, 28, 66, 135, 120, 2, 76.
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.