FDA recall Z-1273-2021

Philips Healthcare (Suzhou) Co., Ltd. · Class II · device

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2021-02-24
Report date
2021-03-24
Termination date
2023-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Suzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2021