Z-2314-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- April 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Allia IGS 3 Pulse angiographic X-ray system
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
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