China NMPA Product Recall - X-ray computed tomography equipment / X-ray computed tomography equipment

Philips (China) Investment Co., Ltd., acting as the agent for Philips Medical Systems DMC GmbH, initiated a voluntary Class III recall for several models of X-ray Computed Tomography (CT) equipment and X-ray measuring equipment. The recall event, detailed in a report dated June 23, 2017, was subsequently publicized by China's National Medical Products Administration (NMPA) on August 8, 2017, under regulatory framework JGXX-2017-10770. The core issue identified was a software anomaly in various scanner versions (4.1.6, 4.2, 4.7.0, and 4.7.2). This defect caused incorrect information from the calcification scoring report to appear in the "Impressions" section of the software output, deviating from the instruction manual which specifies that this critical diagnostic data should be found in the "Findings" section. Affected product models include Brilliance 64, Brilliance CT BigBore, Brilliance iCT, and Ingenuity CT. A total of 28 units were identified as impacted within China. To date, no patient injuries or fatalities have been attributed to this mislabeling. The required action by Philips involves systematically informing all affected customers about the recall procedures. This notification will reiterate the correct usage guidelines and underscore the necessity of adhering strictly to the instruction manual for accurate interpretation of diagnostic information provided by the equipment.