Device recall

Z-1774-2021: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to…

FDA device recall · Class II · Philips North America Llc

Key facts

Recall number (Z-number) Z-1774-2021
Recall event 87872
Product BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Product code JAK
Recalling firm Philips North America Llc
Recall class Class II
Status Terminated
Termination date Sep 23, 2022
510(k) numbers K060937
FEI number 3016618143

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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