InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- November 26, 2013
- Posted
- December 17, 2013
- Terminated
- April 17, 2017
- Recall Number
- Z-0524-2014
- Quantity
- 654
- Firm Location
- Salt Lake City, UT
Reason for Recall
GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
Distribution
Nationwide Distribution
Lot / Code Info
Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
Root Cause
Software Design Change
Action Taken
GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.