FDA Medical Device Recalls (openFDA)
Carbon Medical Technologies, Inc.: BiomarC EX Fiducial Marker System, Catalog Number 040165
- Recall number
- Z-3161-2024
- Recalling firm
- Carbon Medical Technologies, Inc.
- Product
- BiomarC EX Fiducial Marker System, Catalog Number 040165
- Status
- Open, Classified
- Initiated
- 2024-07-26
- Posted
- 2024-09-17
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 00850002461305, Lot Number 2112355B
- 510(k) numbers
- K132064
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3002619738
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28