Device recall

Z-0019-2014: MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray…

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

Key facts

Recall number (Z-number) Z-0019-2014
Recall event 66237
Product MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Product code JAK
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class II
Status Terminated
Termination date Sep 25, 2014
510(k) numbers K083498
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)