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GE Healthcare (China) Co., Ltd. recalls GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999;
Recalled September 4, 2024 · FDA recall Z-2733-2024 · GE Healthcare (China)
Hazard
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install. · FDA Class II
Units
3572 units
Sold at
Worldwide distribution.
Description
The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.
Product
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
Manufacturer(s)
GE Healthcare (China) Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →