Home / Recalls / Medical Devices
GE OEC Medical Systems, Inc recalls OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures durin
Recalled August 29, 2012 · FDA recall Z-2236-2012 · GE OEC Medical Systems
Hazard
GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use. · FDA Class II
Units
99 units
Sold at
Nationwide Distribution.
Description
GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Product
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open 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, MRI, or X-ray.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →