FDA Enforcement
Class II
Ongoing
Allia IGS Pulse angiographic X-ray system
Recall: Z-2317-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2317-2026
- 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 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: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL
Distribution
Worldwide - US Nationwide distribution.
Quantity
5 units