Device recall

Z-2025-2012: OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV…

FDA device recall · Class II · GE OEC Medical Systems, Inc

Key facts

Recall number (Z-number) Z-2025-2012
Recall event 62404
Product OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use…
Product code JAA
Recalling firm GE OEC Medical Systems, Inc
Recall class Class II
Status Terminated
Termination date Jan 28, 2013
510(k) numbers K041932
FEI number 1720753

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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