OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anat...
FDA Recall #Z-2236-2012 — Class II — October 11, 2006
Product Description
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.
Reason for Recall
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
99 units
Distribution
Nationwide Distribution.
Code Information
Model number A857680 with various serial numbers (refer to consignee list).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated