BiomarC ® 040142Recalls & reported problems
Carbon Medical Technologies, Inc. · Fiducial Marker - EX · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858015005080), received between Jul 25, 2024 and Jul 25, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
1 other recall cover devices cleared under the same FDA submission (K132064); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient-Device Incompatibility1
Patient problems
- Local Reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
A RETROSPECTIVE CHART REVIEW STUDY REPORTED THAT A PATIENT EXPERIENCED AN IMMUNE RESPONSE WITH WITH A POSSIBLE ASSOCIATION. THE EVENT RESOLVED WITH MEDICAL MANAGEMENT. THE PATIENT HAD A FULL RECOVERY.
Patient problems: Local Reaction
MAUDE report 19828934 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A RETROSPECTIVE CHART REVIEW STUDY REPORTED THAT A PATIENT EXPERIENCED A DELAY IN TREATMENT DUE TO MARKER MIGRATION AND/OR VISIBILITY ISSUES WITH A PROBABLE ASSOCIATION. THE EVENT RESOLVED WITH OPEN SURGICAL RE-INTERVENTION. THE PATIENT HAD A FULL RECOVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19827650 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132064. One submission often covers many models, so check the product and lot details in each record.
- Z-3161-2024 · Jul 26, 2024 · Open, ClassifiedBiomarC EX Fiducial Marker System, Catalog Number 040165
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- Elekta Medical Linear Accelerator 1552093Elekta Solutions AB · Accelerator, linear, medical5 recalls6 reports
- Elekta Medical Linear Accelerator 1552092Elekta Solutions AB · Accelerator, linear, medical5 recalls0 reports
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- Elekta Medical Linear Accelerator 1550358Elekta Solutions AB · Accelerator, linear, medical4 recalls2 reports
- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.