Carbon Medical Technologies, Inc.: Device Recall
Recall #Z-3161-2024 · 07/26/2024
Class III: Low Risk
Recall Details
- Recall Number
- Z-3161-2024
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- Carbon Medical Technologies, Inc.
- Status
- Ongoing
- Date Initiated
- 07/26/2024
- Location
- Saint Paul, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 boxes of 3 devices
Reason for Recall
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Product Description
BiomarC EX Fiducial Marker System, Catalog Number 040165
Distribution Pattern
US Nationwide distribution in the state of TN.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.