Date Initiated by Firm |
July 12, 2004 |
Date Posted |
May 11, 2005 |
Recall Status1 |
Terminated 3 on August 02, 2011 |
Recall Number |
Z-0815-05 |
Recall Event ID |
31057 |
510(K)Number |
K040050 K983529
|
Product Classification |
System, Image Processing, Radiological - Product Code LLZ
|
Product |
InstaTrak 3500 Plus Navigation and Visualization System |
Code Information |
Axcess System Kit P/N: 1005869-001 |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems,Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact |
GE Healthcare Field Service 801-517-6717
|
Manufacturer Reason for Recall |
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were notified by letter on 07/12/04. |
Quantity in Commerce |
5 kits |
Distribution |
Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities. |
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.
|
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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