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Moderate riskFDA DeviceClass II

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

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.

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

What to do

  1. If you operate or service one of the affected serial numbers (D3-23-024 through D3-26-007), contact GE HealthCare for repair instructions.
  2. Do not perform internal maintenance or troubleshooting inside the C-FRT cabinet while power is on until the cable is repaired.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Allia IGS 7 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
35 units
Illnesses reported
None reported
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Classification
Class II
Recall number
Z-2316-2026

In the FDA's words

Description
Allia IGS 7 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: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 35 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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