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U.S. Department of Health and Human Services

Class 2 Device Recall Navigation and Visualization systems

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  Class 2 Device Recall Navigation and Visualization systems see related information
Date Initiated by Firm December 13, 2004
Date Posted April 08, 2005
Recall Status1 Terminated 3 on July 08, 2011
Recall Number Z-0688-05
Recall Event ID 30758
510(K)Number K960330  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product ENTrak Plus Navigation and Visualization System
Code Information The particular accessories (''Sensors'') involved are: Short Range Transmitter (P/N 1004587 or 1002008); Snap Receiver Cable (P/N 1004069 or 1001989); Extended Range Transmitter (P/N 1004070 or 1003991); and T-Handle Spine Tool Receiver (P/N 1004072).
Recalling Firm/
Manufacturer		 OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact GE Healthcare Customer Service
800-874-7378
Manufacturer Reason
for Recall		 Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
FDA Determined
Cause 2		 Other
Action Customers were notified by letter on 12/13/04.
Quantity in Commerce 67 units
Distribution Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
Total Product Life Cycle TPLC Device Report
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 = VISUALIZATION TECHNOLOGY, INC.
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