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Class 1 Device Recall FluoroTrak Spinal Navigation System |
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Date Initiated by Firm |
April 02, 2007 |
Date Posted |
August 08, 2012 |
Recall Status1 |
Terminated 3 on September 28, 2012 |
Recall Number |
Z-2136-2012 |
Recall Event ID |
62414 |
510(K)Number |
K994270
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
Radiological Image Processing System
The system is an aid to locate anatomical structures during open or 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 CS, MR, or X-ray. |
Code Information |
E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
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For Additional Information Contact |
Ms. Deena Pease 801-536-4952
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Manufacturer Reason for Recall |
The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
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FDA Determined Cause 2 |
Software design |
Action |
GE Healthcare sent an Urgent Recall Notice dated April 2, 2007, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were asked to call 800-874-7378. For questions regarding this recall call 801-536-4952, |
Quantity in Commerce |
17 |
Distribution |
Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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