InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human
FDA device recall Z-0704-2007 · posted 2007-03-30 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
- Action taken
- Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, Ita
- Date initiated
- 2005-01-26
- Date posted
- 2007-03-30
- Date terminated
- 2011-07-08
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTATRAK 3000 (K983529) | Visualization Technology, Inc. | 1998-12-31 |