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GE Medical Systems, LLC: Allia IGS 3 Pulse angiographic X-ray system

Medical DevicesSource: FDA (device) · Date: 2026-06-17

Read the official notice at FDA (device) →

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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
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