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U.S. Department of Health and Human Services

Class 2 Device Recall OEC InstaTrak 3500

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 Class 2 Recall
OEC InstaTrak 3500
see related information
Date Posted August 22, 2012
Recall Status1 Terminated on August 22, 2012
Recall Number Z-2236-2012
Recall Event ID 62744
Premarket Notification
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, Utah 84116-2862
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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 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 = VISUALIZATION TECHNOLOGY, INC.
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