GE Medical Systems, LLC: Allia IGS 3 Pulse angiographic X-ray system

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 9 units Lot/code info: 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

UPC codes

00195278719577

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.