InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
This recall has been terminated (originally issued March 30, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- January 26, 2005
- Posted
- March 30, 2007
- Terminated
- July 8, 2011
- Recall Number
- Z-0704-2007
- Quantity
- 91 systems (version 5.1 software)
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with 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 / Code Info
InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
Root Cause
Other
Action Taken
Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2
More recalls by Ge Oec Medical Systems, Inc
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopi...
Dec 18, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed...
Dec 18, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoro...
Dec 18, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is i...
Dec 18, 2024
OEC 9800 Systems with 9-inch Image Intensifier
Jul 31, 2023