China NMPA Product Recall - X-ray computed tomography equipment

Philips Medical Systems (Cleveland), Inc., in collaboration with its Chinese distributor Philips (China) Investment Co., Ltd., initiated a voluntary recall of its X-ray Computed Tomography Equipment. The recall, reported on September 18, 2014, was overseen by the National Medical Products Administration (NMPA) of China. The core issue stemmed from incorrect slice spacing settings within the CCT protocol user settings, which occurred during a software upgrade from v3.x to v4.0.0/v4.0.1, attributed to a protocol check card conversion error. This defect caused the first image to be erroneously labeled as "last exposure" during CCT examinations, leading to delayed image reconstruction. While all images eventually appeared and no patient injuries were reported, the issue presented a potential operational concern. Notably, the affected product batches were not sold or imported into China. Despite no direct market impact, the NMPA proactively requested all provincial food and drug administrations to enhance supervision and management of similar products, reinforcing regulatory vigilance.