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Open, Classified

BiomarC EX Fiducial Marker System, Catalog Number 040165

FDA Recall Z-3161-2024 · Posted 2024-09-17

Recalling FirmCarbon Medical Technologies, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2024-07-26
Product Quantity25 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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution in the state of TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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