BiomarC EX Fiducial Marker System recalled for missing MRI safety component
Carbon Medical Technologies is recalling the BiomarC EX Fiducial Marker System because patients did not receive the required MRI Insert component needed for safe use during MRI procedures.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device product where the required MRI safety component was not provided. No illnesses or injuries have been reported, but the missing component poses a potential safety risk if the device is used in MRI environments.
Plain-English summary
Carbon Medical Technologies is recalling the BiomarC EX Fiducial Marker System (Catalog Number 040165) that was distributed in Tennessee. The recall affects 25 boxes of 3 devices each (Lot Number 2112355B, UDI/DI 00850002461305).
The company failed to provide the MRI Insert component that is required to be included with each device. This insert is necessary for patient safety during MRI procedures.
If you are using or have received this product, contact your healthcare provider or Carbon Medical Technologies immediately. Do not use the device in MRI environments without the required MRI Insert component. Coordinate with the manufacturer regarding return or replacement of the affected devices.
The recalled product
- Product
- BiomarC EX Fiducial Marker System, Catalog Number 040165
- Manufacturer
- Carbon Medical Technologies, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00850002461305
- Lot Number 2112355B
Distribution
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