Device recall

Z-1623-2015: CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-1623-2015
Recall event 71167
Product CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Product code JAK
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Jul 15, 2015
510(k) numbers K013561
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)