FDA-Device2026-06-17Class IIPROCESSING DEFECT

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

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

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

  • If you own or operate an affected unit, contact GE HealthCare for instructions before performing any work inside the C-FRT cabinet with power on.
  • Do not perform installation, maintenance, or troubleshooting activities inside the cabinet while the system is powered on until you receive further guidance.
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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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