InstaTrak 3500 Navigation and Visualization System
This recall has been terminated (originally issued April 8, 2005).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- December 13, 2004
- Posted
- April 8, 2005
- Terminated
- July 8, 2011
- Recall Number
- Z-0690-05
- Quantity
- 114 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Distribution
Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
Lot / Code Info
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).
Root Cause
Other
Action Taken
Customers were notified by letter on 12/13/04.
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