CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Innova IGS 540 Indicated for use recalled by GE Healthcare

GE Healthcare is recalling Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating, distributed in California, Colorado, Florida, Missouri, Pennsylvania. The recall was initiated on 4 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg Lot or Serial # System ID 00000642076BU4 303695IR1 00000642193BU7 0004040462 00000646910BU0 314768SM10 00000647792BU1 904UFHNSP 00000646492BU9 XV386041GE8 00000646048BU9 S4160099 00000644611BU6 H2009VAS44 00000646493BU7 H0008VAS06 00000645027BU4 XV106184CX5 00000646491BU1 4184240

Quantity recalled10 (4 US, 6 OUS).

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-0451-2015
FDA event ID: 69286
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2014
FDA classified: 12 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

4 Sep 2014	Recall initiated by company
12 Dec 2014	Classified by FDA	+99 days
24 Dec 2014	Published in enforcement report	+12 days

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

Reason for recall

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Product as listed by the FDA

Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Where it was distributed

Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.

California Colorado Florida Missouri Pennsylvania

Questions about this recall

Why was it recalled?

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

Which lots are affected?

Mfg Lot or Serial # System ID 00000642076BU4 303695IR1 00000642193BU7 0004040462 00000646910BU0 314768SM10 00000647792BU1 904UFHNSP 00000646492BU9 XV386041GE8 00000646048BU9 S4160099 00000644611BU6 H2009VAS44 00000646493BU7 H0008VAS06 00000645027BU4 XV106184CX5 00000646491BU1 4184240

Where was it sold?

Worldwide Distribution -- US, including the states of CA, CO, FL, MO, PA; and, the countries of BELGIUM, CHINA, COLOMBIA, FRANCE, GREECE, MEXICO, and RUSSIA.

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.

Other products in this recall event

2 other products · FDA event 69286

Reported	Class	Recall	Company	Reason	Where
24 Dec 2014	CLASS II	Discovery IGS 740 Indicated for use recalled by GE Healthcare	GE Healthcare	Other	5 states
24 Dec 2014	CLASS II	Innova 4100IQ Indicated for use recalled by GE Healthcare	GE Healthcare	Other	5 states

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