China NMPA Product Recall - X-ray computed tomography equipment

Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Level III recall for its X-ray Computed Tomography Equipment, specifically model 728243, which includes the Brilliance CT Big Bore system. The recall, publicly reported by the National Medical Products Administration (NMPA) on August 30, 2016, arose from a manufacturing deviation where a stainless steel fastener was inadvertently used instead of the specified alloy steel. This fastener is crucial for securing adjustable bracket components within the system's scanning gantry. Although internal analysis confirmed the stainless steel fastener met tensile safety factors, concerns were raised regarding its reusability after re-torsion, which may be required for periodic system adjustments throughout its operational life. A total of 24 units were identified as affected in China. Philips has proactively informed all impacted customers about this non-conformity and commenced Field Corrective Actions (FCOs) to implement necessary on-site corrections. Importantly, no patient injuries related to this manufacturing issue have been reported globally. This recall demonstrates Philips' adherence to product safety standards under the NMPA's medical device regulatory framework.