Device recall

Z-0168-2015: COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear…

FDA device recall · Class II · Iba Dosimetry Gmbh

Key facts

Recall number (Z-number) Z-0168-2015
Recall event 69583
Product COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Product code IYE
Recalling firm Iba Dosimetry Gmbh
Recall class Class II
Status Terminated
Termination date Jan 26, 2015
510(k) numbers K072374
FEI number 3006653576

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)