FDA recall Z-0550-2025

GE Healthcare (China) Co., Ltd. · Class II · device

Product

GE Proteus XR/A radiographic system

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-10-24
Report date: 2024-12-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Beijing, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2025