Device recall

Z-1003-2026: Philips Incisive CT

FDA device recall · Class II · Philips Healthcare (Suzhou) Co., Ltd.

Key facts

Recall number (Z-number) Z-1003-2026
Recall event 98238
Product Philips Incisive CT
Product code JAK
Recalling firm Philips Healthcare (Suzhou) Co., Ltd.
Recall class Class II
Status Open, Classified
510(k) numbers K180015, K212441
FEI number 3009529630

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)