Carbon Medical Technologies, Inc. is recalling 25 boxes of the BiomarC EX Fiducial Marker System (Lot Number 2112355B) because they were distributed without required MRI inserts intended for patients. These fiducial markers are implanted into tissue to act as landmarks for radiation therapy or surgical procedures. Without the accompanying MRI insert, patients and healthcare providers may lack critical safety information regarding the marker's compatibility with MRI equipment.
The failure to provide the MRI safety insert means a patient may undergo an MRI scan without the technician knowing a metallic marker is present, which could lead to complications or interference during imaging. Although the risk level is classified as low, accurate safety documentation is essential for patients with implanted medical devices.
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Sources: FDA iRES · Raw API Response
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