← FDA ENFORCEMENT
Z-2318-2026Class II

GE Medical Systems, LLC

Recalling firm
GE Medical Systems, LLC
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
Worldwide - US Nationwide distribution.
Firm state
WI
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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.

Product description

Allia Moveo angiographic X-ray system

Code / lot info

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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.