Reported Jul 18, 2012 · Terminated
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product…
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?
- InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus
- Product UsageUsage: 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 CT, MR, or X-ray
- Lot codes and dates
105 of 105 codes
IT35050PIT35071IT35129IT35133IT35134IT35139IT35140IT35143P-RCIT35144PIT35145P-RCIT35146IT35147P-RCIT35148IT35150IT35153PIT35156IT35161IT35162P-RCIT35164IT35169P-RCIT35170G-RCIT35175IT35182G-RCIT35183P-RCIT35186PIT35187PIT35189PIT35192PIT35193PIT35194PIT35195PIT35200PIT35201PIT35207PIT35208PIT35209PIT35211P-RCIT35214PIT35215PIT35220PIT35222PIT35223PIT35225PIT35228PIT35231PIT35232PIT35234PIT35236PIT35237PIT35240PIT35242PIT35245PIT35248PIT35251PIT35252PIT35253PIT35263PIT35265PIT35269PIT35270P
- Amount recalled
- 86 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
Using this product could cause serious injury, illness or death — stop using it now.
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