Device recall

Z-2596-2025: Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model…

FDA device recall · Class II · Philips North America Llc

Key facts

Recall number (Z-number) Z-2596-2025
Recall event 97468
Product Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Product code JAK
Recalling firm Philips North America Llc
Recall class Class II
Status Open, Classified
510(k) numbers K012009
FEI number 3016618143

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)