FDA-Device2013-12-25Class II

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

GE OEC Medical Systems, Inc

Hazard

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.

Sold states

Nationwide Distribution

Affected count

654

Manufactured in

384 Wright Brothers Dr, N/A, Salt Lake City, UT, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2014

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