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Moderate riskFDA DeviceClass II

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

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.

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

What to do

  1. 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.
  2. Do not perform installation, maintenance, or troubleshooting activities inside the cabinet while the system is powered on until you receive further guidance.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allia IGS Pulse angiographic X-ray system
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
5 units
Illnesses reported
None reported
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Classification
Class II
Recall number
Z-2317-2026

In the FDA's words

Description
Allia IGS 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: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL Distribution: Worldwide - US Nationwide distribution. Affected quantity: 5 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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