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Philips Healthcare (Suzhou) Co., Ltd. recalls Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed to
Recalled March 24, 2021 · FDA recall Z-1273-2021 · Philips Healthcare (Suzhou)
Hazard
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position. · FDA Class II
Units
109 systems
Sold at
Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekistan.
Description
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
Product
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
Manufacturer(s)
Philips Healthcare (Suzhou) Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →