Reported Jun 17, 2026 · Ongoing
Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Allia IGS 3 Pulse angiographic X-ray system
- Lot codes and dates
- UDI-DI00195278719577
- Serial Numbers
M3-24-053M3-24-124M3-25-029M3-25-051M3-25-053M3-25-091M3-25-098M3-25-124M3-26-010M3-26-030
- Amount recalled
- 9 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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