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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62744
Product Type Devices
Status Terminated
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-10-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model number A857680 with various serial numbers (refer to consignee list). Class II 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. 99 units Z-2236-2012
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