Official recall notice
FDA DeviceClass IINotable
FDA Recall: Allia IGS 3 Pulse angiographic X-ray system
- Recall date
- 2026-06-17
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
9 units
Product description
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.