FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems,Inc: InstaTrak 3500 Navigation and Visualization System
- Recall number
- Z-0814-05
- Recalling firm
- GE OEC Medical Systems,Inc
- Product
- InstaTrak 3500 Navigation and Visualization System
- Status
- Terminated
- Initiated
- 2004-07-12
- Posted
- 2005-05-11
- Terminated
- 2011-08-02
- Reason
- Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
- Root cause
- Other
- Action
- Customers were notified by letter on 07/12/04.
- Quantity
- 6 kits
- Distribution
- Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.
- Lot, serial or model codes
- Axcess System Kit P/N: 1005869-001
- 510(k) numbers
- ["K960330","K983529"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28