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Moderate riskFDA DeviceClass II

GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while the system is powered on could be at risk of electrical shock.

From the FDA notice · Read the official notice ↗ · All GE recalls

What to do

  1. If you operate or maintain one of these systems, contact GE HealthCare immediately for instructions on the corrective action.
  2. Do not perform work inside the C-FRT cabinet while the system is powered on until you receive guidance from GE HealthCare.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allia IGS 3 Pulse angiographic X-ray system
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
9 units
Illnesses reported
None reported
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Classification
Class II
Recall number
Z-2314-2026

In the FDA's words

Description
Allia IGS 3 Pulse angiographic X-ray system 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. UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 9 units
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.

5 products in this recall

GE Allia IGS X-ray systems recalled for electrical shock risk

GE HealthCare found a possible problem with an electrical cable in certain Allia IGS X-ray systems that use Gaia generators. The issue could expose service personnel to electrical shock while working inside the C-FRT cabinet with power on. This recall includes 5 product lines, with 173 affected units in total.

The agency lists each product separately. Check every one you might have.

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