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U.S. Department of Health and Human Services

Class 3 Device Recall BiomarC EX Fiducial Marker System

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 Class 3 Device Recall BiomarC EX Fiducial Marker Systemsee related information
Date Initiated by FirmJuly 26, 2024
Date PostedSeptember 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3161-2024
Recall Event ID 95179
510(K)NumberK132064 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductBiomarC EX Fiducial Marker System, Catalog Number 040165
Code Information UDI/DI 00850002461305, Lot Number 2112355B
FEI Number 3002619738
Recalling Firm/
Manufacturer		 Carbon Medical Technologies, Inc.
1290 Hammond Rd
Saint Paul MN 55110-5867
For Additional Information ContactJared Klein
651-653-8512 Ext. 152
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionCarbon 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.
Quantity in Commerce25 boxes of 3 devices
DistributionUS Nationwide distribution in the state of TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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