Philips Healthcare (Suzhou) Co., Ltd. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Class IIJun 26, 2026Potential of failing to trigger clinical scan during Bolus T	Potential of failing to trigger clinical scan during Bolus Tracking.	Class IIDevices	Jun 26, 2026
Philips Incisive CTClass IIDec 3, 2025Potential for incomplete scan due to unstable connection ins	Potential for incomplete scan due to unstable connection inside of floating sensor.	Class IIDevices	Dec 3, 2025
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.Class IIDec 23, 2022Multiple software issues which have the potential to lead to	Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect	Class IIDevices	Dec 23, 2022
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed toClass IIFeb 24, 2021Philips has internally detected an issue with the actuators	Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result	Class IIDevices	Feb 24, 2021