GE Medical Systems, LLC: Allia IGS 3 Pulse angiographic X-ray system
Read the official notice at FDA (device) →
Get alerts for GE Medical Systems
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems, LLC
- Product
- Allia IGS 3 Pulse angiographic X-ray system
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-04-20
- Code info
- UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030
- Product quantity
- 9 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 98880
Free daily digest + "My products" watchlist