Recall Z-3161-2024 ยท IYE Accelerator, Linear, Medical
Carbon Medical Technologies, Inc.
BiomarC EX Fiducial Marker System, Catalog Number 040165
| Date | Sep 17, 2024 (initiated Jul 26, 2024) |
| Status | Open, Classified |
| Reason | This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. |
| Root cause | Employee error |
| Action | Carbon Medical Technologies issued an IMPORTANT" MEDICAL DEVICE RECALL notice to its sole consignee on 07/26/2024 via USPS certified mail and email. The notice explained the issue, the potential risk to the patient, and requested the the return of the affected product. Distributors were directed to notify their customers and to provide them with a copy of the MRI insert to be distributed to the patients. |
| Quantity | 25 boxes of 3 devices |
| Distribution | US Nationwide distribution in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132064 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc., Feb 28, 2014 |