GE Healthcare (China) Co., Ltd. recalls GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373…

Recall date

July 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2733-2024

FDA classification

Class II

Brand / firm

GE Healthcare (China) Co., Ltd.

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

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 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