CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ recalled

GE OEC Medical Systems is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted, distributed nationwide in the US. The recall was initiated on 26 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Quantity recalled654

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0524-2014
FDA event ID: 66992
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 26 Nov 2013
FDA classified: 17 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Nov 2013	Recall initiated by company
17 Dec 2013	Classified by FDA	+21 days
25 Dec 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE OEC Medical Systems

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25 Dec 2024Device	CLASS II	OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC Elite recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 3D recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
9 Aug 2023Device	CLASS II	OEC Elite Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

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