Device recall

Z-0015-2018: Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These…

FDA device recall · Class II · Philips Electronics North America Corporation

Key facts

Recall number (Z-number) Z-0015-2018
Recall event 78144
Product Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code JAK
Recalling firm Philips Electronics North America Corporation
Recall class Class II
Status Terminated
Termination date Feb 26, 2020
FEI number 1218950

At a glance

  • None 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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