Device recall

Z-0142-2022: Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

FDA device recall · Class II · Canon Medical System, USA, INC.

Key facts

Recall number (Z-number) Z-0142-2022
Recall event 88691
Product Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Product code KPS
Recalling firm Canon Medical System, USA, INC.
Recall class Class II
Status Terminated
Termination date Jun 30, 2023
510(k) numbers K203314
FEI number 2020563

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)