China NMPA Product Recall - X-ray equipment, medical X-ray system

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its medical X-ray systems, as reported by the National Medical Products Administration (NMPA) on March 21, 2019. The company identified a critical manufacturing defect involving the gantry/examination table adjustment mechanism. Specifically, it was discovered during after-sales service that one locking plate, essential for securing the height and tilt movement of the gantry/examination table, was missing in some units.

This defect poses a potential safety risk. The absence of the locking plate can lead to inaccurate positioning of the system's axes over time. While some systems exhibited functionality for several years, one unit, after five years of use, showed an inability to correctly position its axes. The most severe consequence of this issue could be an unexpected tilting or movement of the gantry/examination table, which users might not be able to prevent, potentially compromising patient and operator safety.

The recall covers specific X-ray equipment models registered under CFDA (Imported) certificates. Philips (China) is undertaking this action to address the identified product deficiency and ensure the safe operation of its devices in accordance with regulatory standards overseen by the NMPA. Further details on affected products are provided in the "Medical Device Recall Event Report Form".