Device recall

Z-0842-2008: GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-0842-2008
Recall event 46859
Product GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
Product code KPR
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Dec 18, 2011
510(k) numbers K993090
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)