FDA Enforcement
Class II
Ongoing
Allia IGS 3 Pulse angiographic X-ray system
Recall: Z-2314-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2314-2026
- Event ID
- 98880
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Medical Systems, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 17, 2026
- Initiation Date
- April 20, 2026
- Classification Date
- June 5, 2026
- Address
- 3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States
Description
Allia IGS 3 Pulse angiographic X-ray system
Reason
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.
Code Info
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
Distribution
Worldwide - US Nationwide distribution.
Quantity
9 units