GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
GE Allia IGS 5 Pulse X-ray system recalled for electrical shock risk
GE HealthCare identified a potential electrical cable issue on certain Allia IGS 5 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on face a risk of electrical shock.
- If you operate or maintain an affected system, contact GE HealthCare for instructions before performing any work inside the C-FRT cabinet with power on.
- Verify your system's serial number against the affected list provided by GE HealthCare.
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-2315-2026More GE Medical Systems, LLC recalls
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