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Innova Igs 5 001

by GE Medical Systems, LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682124621 UDI-DI Date24 Jan 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

26 recalls · 6 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1783-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1778-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1782-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1777-2024 FDA Class II initiated 18 Mar 2024

    GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

  • 2 recalls, same reason

    • Ongoing Z-1200-2019 FDA Class II initiated 15 Mar 2019
    • Ongoing Z-1201-2019 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.

    • Terminated Z-1864-2021 FDA Class II initiated 19 Apr 2021

    The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.

  • 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-1976-2015 FDA Class II initiated 29 May 2015
    • Terminated Z-1974-2015 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-1981-2015 FDA Class II initiated 29 May 2015
    • Terminated Z-1977-2015 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
    • Terminated Z-1980-2015 FDA Class II initiated 29 May 2015
    • Terminated Z-1982-2015 FDA Class II initiated 29 May 2015
    • Terminated Z-1984-2015 FDA Class II initiated 29 May 2015
    • Terminated Z-1978-2015 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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Innova
Generic Name
Stationary angiographic x-ray system, digital
Model / Reference
IGS 5 001
Primary DI / UDI-DI
00840682124621
510(k) Number
FDA Product Code
JAA, OWB, IZI
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

Related devices

Cleared under the same submission (K122457)

Cleared under the same submission (K181403)

Other devices from GE Medical Systems, LLC

See all devices from GE Medical Systems, LLC →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No