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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 systemssee related information
Date Initiated by FirmDecember 13, 2004
Date PostedApril 08, 2005
Recall Status1 Terminated 3 on July 08, 2011
Recall NumberZ-0692-5
Recall Event ID 30758
510(K)NumberK022069 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
ProductFluroTrak 9800 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 ContactGE 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
ActionCustomers were notified by letter on 12/13/04.
Quantity in Commerce42 units
DistributionDomestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAA
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