Device recall

Z-3161-2024: BiomarC EX Fiducial Marker System, Catalog Number 040165

FDA device recall · Class III · Carbon Medical Technologies, Inc.

Key facts

Recall number (Z-number) Z-3161-2024
Recall event 95179
Product BiomarC EX Fiducial Marker System, Catalog Number 040165
Product code IYE
Recalling firm Carbon Medical Technologies, Inc.
Recall class Class III
Status Open, Classified
510(k) numbers K132064
FEI number 3002619738

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)