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Igs Wf Sp

by GE Medical Systems SCS

Ref 5796561

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08406821BUG004757K Basic UDI-DI 00840682141307UDI-DIDate15 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682141307 UDI-DI Date29 Nov 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

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

    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.

    • 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Foot-switch, electrical
Device Name
Wireless Footswitch
Model / Ref / Catalog
5796561, IGS WF SP
Primary DI / UDI-DI
00840682141307
Basic UDI-DI
08406821BUG004757K
510(k) Number
FDA Product Code
OWB, OXO, IZI, JAA
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
GMDN Term
Foot-switch, electrical
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650, 892.1600
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5796561
GUDID
IGS WF SP
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000687

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No