FDAClass IIDecember 25, 2013

InstaTrak¿ 3500 Plus recall

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

Why was InstaTrak¿ 3500 Plus recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Product
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Recalling firm
GE OEC Medical Systems, Inc
Quantity
654
Distribution
Nationwide Distribution
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls