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U.S. Department of Health and Human Services

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

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 Class 1 Recall
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P
see related information
Date Posted August 28, 2012
Recall Status1 Terminated on September 28, 2012
Recall Number Z-2251-2012
Recall Event ID 62715
Premarket Notification
510(K) Numbers
K003510  K040050  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, Utah 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 2
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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