Device recall

Z-1565-2008: GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-1565-2008
Recall event 46807
Product GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain.
Product code JAA
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Aug 9, 2012
510(k) numbers K041605
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

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