China NMPA Product Recall - X-ray computed tomography (CT) system

On April 20, 2015, Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall for its X-ray Computed Tomography (CT) Systems, specifically the Brilliance iCT model. The recall stemmed from the discovery that a torque wrench utilized by a supplier for securing critical bolts failed a follow-up calibration test. This deficiency created an unacceptable risk of bolt failure, which could potentially lead to the detachment of the X-ray tube assembly during scanning. While this issue carried the potential for serious harm, no injuries related to this defect had been reported globally at the time of the recall. For the Chinese market, only one affected unit was identified, which was still in the installation phase by Philips engineers and had not yet been handed over to a customer. This meant there was no immediate risk to clinical operations in China. To rectify the issue, Philips committed to on-site corrective actions. Field service engineers were instructed to replace the original bolts on the affected system during its installation, ensuring the equipment's integrity and safety before its official delivery to the customer. This proactive measure was reported to the National Medical Products Administration (NMPA) to address the identified safety concern effectively.