Medical device recalls Moderate risk

GE Healthcare (China) Co., Ltd. recalls GE Proteus XR/A radiographic system

Recall date
October 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0550-2025
FDA classification
Class II
Brand / firm
GE Healthcare (China) Co., Ltd.
Sold / distributed
Worldwide - US Nationwide distribution.

Why it was recalled

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Proteus XR/A radiographic system

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