Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
InstaTrak with Multiple Dataset Navigation Recalled by GE OEC Medical Systems, Inc Due to Please be aware that this is not a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE OEC Medical Systems, Inc directly.
Affected Products
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: 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.
Quantity: 86 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE OEC Medical Systems, Inc
GE OEC Medical Systems, Inc has 48 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report