GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
What this means
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.
- If you operate or maintain one of these systems, contact GE HealthCare immediately for instructions on the corrective action.
- Do not perform work inside the C-FRT cabinet while the system is powered on until you receive guidance from GE HealthCare.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2314-2026More GE recalls
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