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Igs 5

by GE Medical Systems SCS 2 variants

Ref 5943307Model Allia

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

7 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
United StatesGUDID listing GUDID Number00195278719263 UDI-DI Date8 Dec 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00099HR Basic UDI-DI 00195278719263UDI-DIDate4 Mar 2022RegisteredStatusActive

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

7 recalls · 7 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2314-2026 FDA Class II initiated 20 Apr 2026
    • Ongoing Z-2317-2026 FDA Class II initiated 20 Apr 2026
    • Ongoing Z-2315-2026 FDA Class II initiated 20 Apr 2026
    • Ongoing Z-2316-2026 FDA Class II initiated 20 Apr 2026

    GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

  • 3 recalls, same reason

    • Ongoing Z-1779-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1780-2024 FDA Class II initiated 18 Mar 2024
    • Ongoing Z-1781-2024 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.

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  • Withdrawn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

Trade Name
Igs 5 EUDAMED
Allia GUDID
Generic Name
Stationary angiographic x-ray system, digital
Model / Ref / Catalog
Allia, 5943307, IGS 5
Primary DI / UDI-DI
00195278719263
Basic UDI-DI
8406821BUG00099HR
510(k) Number
FDA Product Code
JAA, IZI, OWB
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
GMDN Term
Stationary angiographic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650, 892.1600
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Allia
5943307
GUDID
IGS 5
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

Other properties (22)

  • 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
  • Manufacturing Date: No