BiomarC EX Fiducial Marker System, Catalog Number 040165
FDA device recall Z-3161-2024 · posted 2024-09-17 · Open, Classified
Recall details
- Recalling firm
- Carbon Medical Technologies, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 25 boxes of 3 devices
- Distribution
- US Nationwide distribution in the state of TN.
- Date initiated
- 2024-07-26
- Date posted
- 2024-09-17
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMARC FIDUCIAL MARKER (K132064) | Carbon Medical Technologies, Inc. | 2014-02-28 |