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InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Syste...

FDA Recall #Z-0524-2014 — Class II — November 26, 2013

Recall #Z-0524-2014 Date: November 26, 2013 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

GE OEC Medical Systems, Inc — Salt Lake City, UT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

654

Distribution

Nationwide Distribution

Code Information

Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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