GE Medical Systems, LLC — Class II: Allia IGS 3 Pulse angiographic X-ray system
GE HealthCare identified a potential electrical cable issue in certain Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators. This defect poses a risk of electrical shock to personnel performing service or maintenance inside the C-FRT cabinet while the system remains powered.
GE Medical Systems, LLC, and service personnel involved in the installation, maintenance, or troubleshooting of Allia IGS 3 Pulse angiographic X-ray systems.
This recall highlights a specific occupational safety risk rather than a direct patient safety issue, though service interruptions could impact clinical workflows. Regulatory teams should recognize this as a post-market safety correction focused on the hardware interface (C-FRT cabinet cabling). The ongoing status suggests that field corrections or updated service instructions may be necessary to mitigate shock hazards during live-power diagnostic activities.
Quality and Service departments should verify if their inventory includes IGS systems with Gaia generators. Ensure that service manuals and safety protocols explicitly prohibit or strictly control internal C-FRT cabinet access while power is active. Review internal training records for service personnel to reinforce electrical safety compliance during troubleshooting.
Class II. Reason: 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.. Product: Allia IGS 3 Pulse angiographic X-ray system. Firm: GE Medical Systems, LLC (Waukesha WI United States). Status: Ongoing.
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