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Recall Observatory FDA recall evidence

Device product

Allia Moveo angiographic X-ray system

Z-2318-2026

April 20, 2026

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 98880
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2318-2026

Official wording

Reason: 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.

Code information: UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.