FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems,Inc: InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
- Recall number
- Z-0704-2007
- Recalling firm
- GE OEC Medical Systems,Inc
- Product
- InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
- Status
- Terminated
- Initiated
- 2005-01-26
- Posted
- 2007-03-30
- Terminated
- 2011-07-08
- Reason
- Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
- Root cause
- Other
- Action
- Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2
- Quantity
- 91 systems (version 5.1 software)
- Distribution
- Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada
- Lot, serial or model codes
- InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
- 510(k) numbers
- ["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