FDA Device

ENTrak Navigation and Visualization System

Hazard

Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

What You Should Do

Remedy

Customers were notified by letter on 12/13/04.

Products

ENTrak Navigation and Visualization System
Brand
OEC Medical Systems, Inc
UPC
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).

Units Affected

99 units