Device product
Mammotrak Interventional Coil 1.5T
Z-0542-2025
Product summary
- Event
- Event 95645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,231 units
- Official record key
device-enforcement:Z-0542-2025
Official wording
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Code information: REF: 453530228882; UDI-DI: 00884838066779; Serial No. 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, 131.
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.