Class 2 Device Recall OEC InstaTrak 3500

• Date Initiated by Firm: October 11, 2006
• Date Posted: August 22, 2012
• Recall Status: Terminated on August 22, 2012
• Recall Number: Z-2236-2012
• Recall Event ID: 62744
• 510(K)Number: K003510
• Product Classification: System, image processing, radiological - Product Code LLZ
• 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.
• Code Information: Model number A857680 with various serial numbers (refer to consignee list).
• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Ms. Deena Pease; 801-536-4952
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: GE Healthcare sent an "URGENT SAFETY ADVISORY NOTICE" dated October 11, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter stated that GEHC OEC Field Service Engineers would be contacting their facility to place a caution label on the articulating monitor arm of the cart and to provide a revised operators manual that will contain additional information on the safe usage of the cart. Until a GEHC Engineer had taken the actions described, they advised their consignees to exercise caution when fully extending the articulating monitor arm on the device to avoid potentially tipping over the cart. Contact the firm at 800-874-7378 for questions regarding this notice.
• Quantity in Commerce: 99 units
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ