Device recall

Z-0955-2015: The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-0955-2015
Recall event 70133
Product The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction…
Product code JAK
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Apr 29, 2015
510(k) numbers K133705
FEI number 2126677

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)