Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 2/18/2021, Philips issued an Urgent Medical Device Correction because the firm has detected an issue with some actuators used in the couch of Incisive CT and Access CT systems, which could result in the couch unexpectedly moving slowly downward to its limit position.