Z-3161-2024Class III

BiomarC EX Fiducial Marker System, Catalog Number 040165

Name: Z-3161-2024 BiomarC EX Fiducial Marker System, Catalog Number 040165
Creator: Carbon Medical Technologies, Inc.
Published: 2024-07-26
License: https://open.fda.gov/license/

Carbon Medical Technologies, Inc. / initiated 2024-07-26 / Open, Classified / root cause: manufacturing process

FDA source

Carbon Medical Technologies, Inc. began a recall of BiomarC EX Fiducial Marker System, Catalog Number 040165 on 2024-07-26. FDA classified it as Class III and gives the reason as "This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3161-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-07-26
Posted: 2024-09-17
Recalling firm: Carbon Medical Technologies, Inc.
Product: BiomarC EX Fiducial Marker System, Catalog Number 040165
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 25 boxes of 3 devices
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: UDI/DI 00850002461305, Lot Number 2112355B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3161-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3161-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-17

Product code IYE

K132064Class IIBiomarc Fiducial MarkerCarbon Medical Technologies, Inc. / cleared 2014-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)