Device recall

Z-1613-2008: Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle…

FDA device recall · Class III · Med Tec Inc dba CIVCO Medical Solutions

Key facts

Recall number (Z-number) Z-1613-2008
Recall event 46905
Product Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
Product code IYE
Recalling firm Med Tec Inc dba CIVCO Medical Solutions
Recall class Class III
Status Terminated
Termination date Jul 2, 2008
510(k) numbers K071614
FEI number 1000143606

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)