Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
OEC IT3000 Recalled by GE OEC Medical Systems, Inc Due to GE Healthcare Surgery had discovered that using the...
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
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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, MRI, or X-ray.
Quantity: 768 units
Why Was This Recalled?
GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
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