FDA-Device2026-06-17Class IIPROCESSING DEFECT

Allia IGS Pulse angiographic X-ray system

ELECTRICAL SHOCKNationwide distribution
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.

Sold states
Worldwide - US Nationwide distribution.
Affected count
5 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Allia IGS Pulse angiographic X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2026

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