FDAHealthApril 20, 2026
GE Medical Systems, LLC — Allia IGS 3 Pulse angiographic X-ray system
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 20, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- Allia IGS 3 Pulse angiographic X-ray system
- Lot code
- UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030
Additional details
UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9 units.
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