FDA recall Z-3161-2024

Carbon Medical Technologies, Inc. · Class III · device

Product

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.

Distribution

US Nationwide distribution in the state of TN.

Key facts

Status
Ongoing
Initiation date
2024-07-26
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3161-2024