Carbon Medical recalls BiomarC EX Fiducial Marker System (Catalog 040165) due to potential missing MRI insert. Affected units may not function properly in MRI scans.
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Carbon Medical is recalling its BiomarC EX Fiducial Marker System (Catalog Number 040165) because it may not have the required MRI insert. This could prevent proper MRI imaging for patients.
The device requires a specific MRI insert to function correctly during MRI scans. Without this insert, the system may not work properly, potentially leading to incorrect imaging results.
Patients using this system for MRI scans may be affected if the required MRI insert is missing. Medical facilities that use this device are most at risk.
Check for the Catalog Number 040165 on the device. The UDI/DI number is 00850002461305 and the lot number is 2112355B.
Verify the Catalog Number 040165, UDI/DI 00850002461305, and Lot Number 2112355B on the device.
The recall is initiated because the device may not have the required MRI insert, which is necessary for proper MRI imaging.
Check the device for the Catalog Number 040165, UDI/DI 00850002461305, and Lot Number 2112355B. No specific action is required beyond verification.
The recall addresses potential imaging issues, not direct injury risks. The hazard is low risk as it affects device functionality, not safety.
We’ve drafted a message you can send Carbon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3161-2024 — Carbon Medical Carbon Medical Hello, I own a Carbon Medical that is covered by recall Z-3161-2024 from Carbon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
