CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Innova IGS recalled by GE Healthcare

GE Healthcare is recalling Innova IGS 520, distributed nationwide in the US. The recall was initiated on 29 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026 0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02

Quantity recalled10

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-1980-2015
FDA event ID: 71508
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2015
FDA classified: 2 Jul 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

29 May 2015	Recall initiated by company
2 Jul 2015	Classified by FDA	+34 days
8 Jul 2015	Published in enforcement report	+6 days

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

Reason for recall

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

Product as listed by the FDA

GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Where it was distributed

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.

Nationwide California Delaware Florida Georgia Illinois Indiana Kansas Mississippi Nevada Ohio Oklahoma Oregon Pennsylvania Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026 0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02

Where was it sold?

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

Other products in this recall event

12 other products · FDA event 71508

This product is part of a recall event; the main page for the event is Optima IGS recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2015	CLASS II	Optima IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Discovery IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Optima CL 323i recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova 2121IQ recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova 2100IQ recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Discovery IGS 740 & GE Healthcare Innova IGS recalled	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova 3100IQ recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova IGS recalled by GE Healthcare	GE Healthcare	Other	Nationwide
8 Jul 2015	CLASS II	Innova 3131IQ recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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