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-2317-2026More GE Medical Systems, LLC recalls
- FDA-Device2026-06-17Allia IGS 3 Pulse angiographic X-ray system
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-05-20GE Revolution CT ES X-ray systems recalled for AW Server security vulnerability
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