FDA-Device2021-03-24Class II
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.
Philips Healthcare (Suzhou) Co., Ltd.
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.
Sold states
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.
Affected count
109 systems
Manufactured in
Suzhou Industrial Park, No. 258 Zhongyuan Road, Suzhou, N/A, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief