GE OEC Medical Systems, Inc InstaTrak 3500 Plus Navigation and Visualization System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InstaTrak 3500 Plus Navigation and Visualization System
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Axcess System Kit P/N: 1005869-001
Products Sold
Axcess System Kit P/N: 1005869-001
GE OEC Medical Systems, Inc is recalling InstaTrak 3500 Plus Navigation and Visualization System due to Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
Recommended Action
Per FDA guidance
Customers were notified by letter on 07/12/04.
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 noticeDistribution
As reported by FDA
CA, CT, KY, LA, NJ, OK, OR, PA, TN, VA
Page updated: Jan 10, 2026