FDA-Device2026-06-17Class IIPROCESSING DEFECT

GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

GE HealthCare identified a faulty electrical cable on certain Allia IGS 7 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel working inside the C-FRT cabinet while the system is powered on could receive an electrical shock during installation, maintenance, or troubleshooting.

  • If you operate or service one of the affected serial numbers (D3-23-024 through D3-26-007), contact GE HealthCare for repair instructions.
  • Do not perform internal maintenance or troubleshooting inside the C-FRT cabinet while power is on until the cable is repaired.
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
35 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Allia IGS 7 Pulse angiographic X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2026

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