FDA-Device2026-06-17Class IIPROCESSING DEFECT

GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel

ELECTRICAL SHOCKNationwide distribution

GE Allia IGS 5 Pulse X-ray system recalled for electrical shock risk

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 5 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on face a risk of electrical shock.

  • If you operate or maintain an affected system, contact GE HealthCare for instructions before performing any work inside the C-FRT cabinet with power on.
  • Verify your system's serial number against the affected list provided by GE HealthCare.
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
121 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Allia IGS 5 Pulse angiographic X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2315-2026

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