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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

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

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.