Device recall

Z-2346-2016: MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic…

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

Key facts

Recall number (Z-number) Z-2346-2016
Recall event 74402
Product MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Product code JAK
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class II
Status Terminated
Termination date Jul 2, 2018
510(k) numbers K091195
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)