Recall Z-3161-2024— Carbon Medical Technologies, Inc.

Name: FDA recall Z-3161-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-26

Class III · Ongoing

Class III FDA medical device recall by Carbon Medical Technologies, Inc., initiated 2024-07-26. It names one FDA 510(k) clearance: K132064. Product: BiomarC EX Fiducial Marker System, Catalog Number 040165. Reason: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient..

Recalling firm: Carbon Medical Technologies, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2024-07-26
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K132064 — BIOMARC FIDUCIAL MARKERCarbon Medical Technologies, Inc.·cleared 2014-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BiomarC EX Fiducial Marker System, Catalog Number 040165

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.