Reported Aug 15, 2012 · Terminated
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous…
GE OEC Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
- Lot codes and dates
E9-0002-GES-0013-GE9-0036-GE9-0040-GE9-0041-GES-0014-GES-0016-GES-0033-GES-0043-GES-0041-GES-0042-GES-OO84-GES-0086-GES-0163-GE9-0089-GES-0026-GES-0044-G
- Amount recalled
- 17
Where it was sold
Why it was recalled
Stop using this product now
The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
Using this product could cause serious injury, illness or death — stop using it now.
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