Innova Igs 530 002

• • Ongoing Z-1200-2019 FDA Class II ·initiated 15 Mar 2019

  There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

• 2 recalls, same reason

  • Terminated Z-2386-2018 FDA Class II ·initiated 29 Mar 2018
  • Terminated Z-2387-2018 FDA Class II ·initiated 29 Mar 2018

  The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

• • Terminated Z-0763-2016 FDA Class II ·initiated 18 Dec 2015

  GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.

• • Terminated Z-0413-2016 FDA Class II ·initiated 13 Nov 2015

  GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .

• • Terminated Z-0414-2016 FDA Class II ·initiated 13 Nov 2015

  GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.

• 12 recalls, same reason

  • Terminated Z-1980-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1982-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1976-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1984-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1973-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1979-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1974-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1981-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1977-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1978-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1985-2015 FDA Class II ·initiated 29 May 2015
  • Terminated Z-1983-2015 FDA Class II ·initiated 29 May 2015

  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).

• • Terminated Z-0451-2015 FDA Class II ·initiated 4 Sep 2014

  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.

• • Terminated Z-0853-2014 FDA Class II ·initiated 15 Nov 2013

  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

Trade Name

Innova

Generic Name

Stationary angiographic x-ray system, digital

Model / Reference

IGS 530 002

Primary DI / UDI-DI

00840682110662

510(k) Number

K122457 ↗

FDA Product Code

JAA, IZI, OWB

GMDN Term

Stationary angiographic x-ray system, digital

Device Class

Class II

Regulation Number

892.1650, 892.1600

GUDID distribution status

Not in Commercial Distribution

• Discovery MI Gen2

  Class IIb

  CE/MDR

• CortexID Suite

  Class IIa

  CE/MDD

• not applicable PRISTINA 2.10

  Class II

  GUDID on market

• SenoIris 1

  Class II

  GUDID on market

• Thoracic Vcar

  Class II

  FDA 510(k) K103480 Active Cleared 7 Mar 2011

• MaxFOV 2

  Class II

  FDA 510(k) K203617 Active Cleared 2 Mar 2021

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