FDA-Device2024-12-04Class II
GE Proteus XR/A radiographic system
GE Healthcare (China) Co., Ltd.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
956 systems
Manufactured in
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing, China
Products
GE Proteus XR/A radiographic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2025Don't want to check this manually?
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