BiomarC EX Fiducial Marker System, Catalog Number 040165 recallZ-3161-2024 · Carbon Medical Technologies, Inc. · initiated Jul 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carbon Medical Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
FDA root cause category: Employee error
What the company is doing
Carbon Medical Technologies issued an IMPORTANT" MEDICAL DEVICE RECALL notice to its sole consignee on 07/26/2024 via USPS certified mail and email. The notice explained the issue, the potential risk to the patient, and requested the the return of the affected product. Distributors were directed to notify their customers and to provide them with a copy of the MRI insert to be distributed to the patients.
Recall details
- Recall number
- Z-3161-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2024
- Posted by the FDA
- Sep 17, 2024
- Recalling firm
- Carbon Medical Technologies, Inc.
- Quantity
- 25 boxes of 3 devices
- Product code
- IYE
- FDA submissions
- K132064
- Distribution
- US Nationwide distribution in the state of TN.
Product description
BiomarC EX Fiducial Marker System, Catalog Number 040165
Code information (models, lots, serial numbers)
UDI/DI 00850002461305, Lot Number 2112355B
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIOMARC ® EX 040165Carbon Medical Technologies, Inc. · Accelerator, Linear, Medical1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K132064 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BiomarC ® 040142Carbon Medical Technologies, Inc. · Accelerator, Linear, Medical2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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