Class 1 Device Recall OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P

• Date Initiated by Firm: June 22, 2009
• Date Posted: August 28, 2012
• Recall Status: Terminated on September 28, 2012
• Recall Number: Z-2251-2012
• Recall Event ID: 62715
• 510(K)Number: K960330 K981998 K982994 K983529 K990919 K994270
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: 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.
• Code Information: All serial numbers.
• 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; 801-536-4516
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling False and Misleading
• Action: GE Healthcare sent an Urgent Safety Advisory Notice dated June 22, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised not to use the ENT registration Headset in the inverted position for any CT scans or surgical procedures and to remove all references in their Naviation System Operator's Manual that discuss an inverted headset placement, and replace it with the enclosed updated instructions for the Navigation System Operator's Manual. For any questions customers should contact the service team for further information at 800-874-7378, option #8. For questions regarding this recall call 801-536-4516.
• Quantity in Commerce: 768 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.
• 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