OEC Medical Systems, Inc InstaTrak 3000 Navigation and Visualization System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InstaTrak 3000 Navigation and Visualization System
Brand
OEC Medical Systems, Inc
Lot Codes / Batch Numbers
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).
Products Sold
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).
OEC Medical Systems, Inc is recalling InstaTrak 3000 Navigation and Visualization System due to Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Recommended Action
Per FDA guidance
Customers were notified by letter on 12/13/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026