Class III

Medical Device Recall: BiomarC EX Fiducial Marker System, Catalog Number 040165

Carbon Medical Technologies, Inc. · July 26, 2024

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.

Distribution

US Nationwide distribution in the state of TN.

States Affected

NATIONWIDE

Quantity Affected

25 boxes of 3 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3161-2024

Status: ongoing

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