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Allia IGS 5Recalls & reported problems

Ge Medical Systems · Allia IGS5 UDI · Class 2

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

6 other recalls cover devices cleared under the same FDA submission (K232344); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 20, 2026Open, Classified

    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.

    Z-2315-2026 · Root cause: Device Design · FDA record ↗

  2. Mar 18, 2024Open, Classified

    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.

    Z-1782-2024 · Root cause: Process control · FDA record ↗

  3. Mar 18, 2024Open, Classified

    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.

    Z-1783-2024 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232344. One submission often covers many models, so check the product and lot details in each record.

  • Z-2317-2026 · Apr 20, 2026 · Open, Classified
    Allia IGS Pulse angiographic X-ray system
  • Z-2316-2026 · Apr 20, 2026 · Open, Classified
    Allia IGS 7 Pulse angiographic X-ray system
  • Z-2314-2026 · Apr 20, 2026 · Open, Classified
    Allia IGS 3 Pulse angiographic X-ray system
  • Z-1781-2024 · Mar 18, 2024 · Open, Classified
    GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
  • Z-1780-2024 · Mar 18, 2024 · Open, Classified
    GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
  • Z-1779-2024 · Mar 18, 2024 · Open, Classified
    GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

Other System, x-ray, fluoroscopic, image-intensified devices

All System, x-ray, fluoroscopic, image-intensified devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.