China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary Level III recall for 40 units of its X-ray Computed Tomography Equipment, specifically involving serial number 345165. This critical action was formally reported to the National Medical Products Administration (NMPA) through the Jiangsu Provincial Drug Administration. The primary concern arose from observations during installation, revealing that undetected severe wear on the monitor bracket assembly shaft could lead to the complete detachment of the monitor bracket assembly from its suspension arm. This issue, pertinent to the digital video interface used in continuous CT fluorescence examinations, poses a potential safety risk. While Philips confirms that no serious patient-related incidents have been reported concerning this defect, the company is undertaking this recall as a preventative measure to uphold product safety standards and regulatory compliance. To address the identified problem, Philips will implement comprehensive corrective actions, including general repair and system inspections, through two distinct field change orders: FCO 72800751 and FCO 72800752, respectively. These required actions underscore Philips' commitment to resolving the potential hazard and ensuring the safe operation of its medical imaging devices.