Device product

InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

Z-0524-2014

November 26, 2013

Class II

Product summary

Firm: GE OEC Medical Systems, Inc
Event: Event 66992
Status: Terminated
Classification: Class II
Quantity: 654
Official record key: device-enforcement:Z-0524-2014

Official wording

Reason: 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.

Code information: Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.