Device recall

Z-3042-2026: Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT…

FDA device recall · Class II · Philips North America Llc

Key facts

Recall number (Z-number) Z-3042-2026
Recall event 99784
Product Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Product code JAK
Recalling firm Philips North America Llc
Recall class Class II
Status Open, Classified
510(k) numbers K160743
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

Browse all FDA device recalls (products)