FDA Device recall Z-3161-2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
- FDA Device
- Class III
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class III recall of BiomarC EX Fiducial Marker System, Catalog Number 040165 by Carbon Medical Technologies, citing this recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3161-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-07-26 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carbon Medical Technologies |
| Distribution | US |
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.
Identifiers
| code_info | UDI/DI 00850002461305, Lot Number 2112355B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3161-2024%22
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