Allia IGS 3Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier, 1 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-2314-2026 · Root cause: Device Design · 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-2315-2026 · Apr 20, 2026 · Open, Classified
  Allia IGS 5 Pulse angiographic X-ray system
• Z-2316-2026 · Apr 20, 2026 · Open, Classified
  Allia IGS 7 Pulse angiographic X-ray system
• Z-2317-2026 · Apr 20, 2026 · Open, Classified
  Allia IGS 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