Medical device recalls

Carbon Medical Technologies, Inc. recalls BiomarC EX Fiducial Marker System, Catalog Number 040165

Recall date
July 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3161-2024
FDA classification
Class III
Brand / firm
Carbon Medical Technologies, Inc.
Sold / distributed
US Nationwide distribution in the state of TN.

Why it was recalled

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

BiomarC EX Fiducial Marker System, Catalog Number 040165

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