CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report

Innova IGS recalled by GE Healthcare

GE Healthcare is recalling Innova IGS 630, distributed nationwide in the US. The recall was initiated on 15 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # System ID 00000616724BU1 956389IGS630 00000618156BU4 MCMIGS630 FMI12200DUMMY2 702731ANGIO2 00000619372BU6 732828IGS30 00000618158BU0 210705CATH1 00000622076BU9 661327IGS630 00000621314BU4 904202WCL2 00000628656BU1 281MHWCL1 00000622220BU2 303839CL4 00000625357BU9 281420LAB3BP 00000626085BU5 817BGIGS630 00000628654BU6 215576IGS4 FMI12200DUMMY3 CS1340VA01 00000614683BU1 M4152252 00000618160BU6 YV1900 00000617143BU3 YV1901 00000618157BU2 YV1902 00000620495BU2 YV1903 00000624842BU1 YV1904 00000627935BU0 YV1905 00000630300BU2 YV1906 00000617142BU5 YV1950 FMI12200DUMMY4 YV1907 00000622672BU4 850060746 00000626239BU8 850060749 FMI12200DUMMY1 SA2308VA01 00000622221BU0 ZA2239VA01 00000614682BU3 34006VAS02

Quantity recalled28 (12 US, 16 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-0853-2014
FDA event ID: 67325
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 15 Nov 2013
FDA classified: 28 Jan 2014
Reported: 5 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Nov 2013	Recall initiated by company
28 Jan 2014	Classified by FDA	+74 days
5 Feb 2014	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 Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring

Product as listed by the FDA

GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are 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. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.

Nationwide California Colorado Florida New Jersey Nevada Pennsylvania Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial # System ID 00000616724BU1 956389IGS630 00000618156BU4 MCMIGS630 FMI12200DUMMY2 702731ANGIO2 00000619372BU6 732828IGS30 00000618158BU0 210705CATH1 00000622076BU9 661327IGS630 00000621314BU4 904202WCL2 00000628656BU1 281MHWCL1 00000622220BU2 303839CL4 00000625357BU9 281420LAB3BP 00000626085BU5 817BGIGS630 00000628654BU6 215576IGS4 FMI12200DUMMY3 CS1340VA01 00000614683BU1 M4152252 00000618160BU6 YV1900 00000617143BU3 YV1901 00000618157BU2 YV1902 00000620495BU2 YV1903 00000624842BU1 YV1904 00000627935BU0 YV1905 00000630300BU2 YV1906 00000617142BU5 YV1950 FMI12200DUMMY4 YV1907 00000622672BU4 850060746 00000626239BU8 850060749 FMI12200DUMMY1 SA2308VA01 00000622221BU0 ZA2239VA01 00000614682BU3 34006VAS02

Where was it sold?

Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.

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.

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