Device recall

Z-0675-2013: Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269…

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

Key facts

Recall number (Z-number) Z-0675-2013
Recall event 63393
Product Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction…
Product code JAK
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class II
Status Terminated
Termination date Feb 14, 2014
510(k) numbers K961464
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

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