[pending] Allia IGS Pulse angiographic X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-2317-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Allia IGS Pulse angiographic X-ray system
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI-DI: 00195278827647
- Serial Numbers: DVMSS2500001HL
- DVMSS2500002HL
- DVMSS2500003HL
- DVMSS2500004HL
- DVMSS2500005HL
- DVMSS2500006HL
- DVMSS2600001HL
- DVMSS2600002HL
Distribution
Distributed nationwide across the United States.
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