Device recall

Z-1511-2008: Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System…

FDA device recall · Class III · Philips Medical Systems (Cleveland) Inc

Key facts

Recall number (Z-number) Z-1511-2008
Recall event 45894
Product Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Product code KPS
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class III
Status Terminated
Termination date Feb 25, 2012
510(k) numbers K964712
FEI number 1525965

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)