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

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) systems, including the Ingenuity CT. This action was reported to the National Medical Products Administration (NMPA) on May 9, 2016, with public notification on July 6, 2016. The recall stems from a manufacturing deviation where two critical fasteners, intended to be made of alloy steel, were instead produced using stainless steel. These fasteners secure components of the adjustment bracket within the CT system gantry. Although no failures have been reported, Philips' analysis indicates that while the stainless steel fasteners initially meet tensile safety factors, repeated adjustments to the bracket could necessitate re-torsion of these components. Over time, repeated torsion might cause stresses approaching the ultimate yield strength of the stainless steel, potentially compromising the system's integrity. To proactively address this potential risk, Philips has implemented a Field Corrective Action. This involves direct communication with affected customers and the dispatch of Philips Field LLC engineers to replace the non-conforming stainless steel fasteners on all impacted equipment globally. This measure ensures the long-term reliability and safety of the CT systems in line with NMPA's medical device oversight.