GE Allia IGS Pulse 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 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while power is on could be exposed to electrical shock.
- If you own or operate an affected unit, contact GE HealthCare for instructions before performing any work inside the C-FRT cabinet with power on.
- Do not perform installation, maintenance, or troubleshooting activities inside the cabinet while the system is powered on until you receive further guidance.
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-2317-2026More GE recalls
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