CLASS III ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
BiomarC EX Fiducial Marker System recalled
Carbon Medical Technologies is recalling BiomarC EX Fiducial Marker System, distributed nationwide in the US. The recall was initiated on 26 Jul 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3161-2024
- FDA event ID
- 95179
- Recalling firm
- Carbon Medical Technologies, Saint Paul, MN
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Jul 2024
- FDA classified
- 17 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 26 Jul 2024 | Recall initiated by company | |
| 17 Sep 2024 | Classified by FDA | +53 days |
| 25 Sep 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BiomarC EX Fiducial Marker System, Catalog Number 040165
Where it was distributed
US Nationwide distribution in the state of TN.
Questions about this recall
Why was it recalled?
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Which lots are affected?
UDI/DI 00850002461305, Lot Number 2112355B
Where was it sold?
US Nationwide distribution in the state of TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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