Philips Headquarters Cambridge FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 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
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144Class IIApr 12, 2023Potential for Incorrect Image Orientation resulting images m	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis,	Class IIDevices	Apr 12, 2023
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)Class IIApr 12, 2023Potential for Incorrect Image Orientation resulting images m	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis,	Class IIDevices	Apr 12, 2023
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)Class IIApr 12, 2023Potential for Incorrect Image Orientation resulting images m	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis,	Class IIDevices	Apr 12, 2023
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)Class IIApr 12, 2023Potential for Incorrect Image Orientation resulting images m	Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis,	Class IIDevices	Apr 12, 2023