Device recall

Z-0369-2008: GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-0369-2008
Recall event 46680
Product GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console computer and touch screen fullly integrated. the GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations.
Product code JAA
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Aug 9, 2012
510(k) numbers K011624
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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