Device product
BiomarC EX Fiducial Marker System, Catalog Number 040165
Z-3161-2024
Product summary
- Event
- Event 95179
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 25 boxes of 3 devices
- Official record key
device-enforcement:Z-3161-2024
Official wording
Reason: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Code information: UDI/DI 00850002461305, Lot Number 2112355B
Distribution pattern: US Nationwide distribution in the state of TN.
Derived failure modes
-
Unknown
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.