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

Philips (China) Investment Co., Ltd., in coordination with manufacturer Philips Medical Systems DMC GmbH, initiated a voluntary Level III recall of certain X-ray Computed Tomography (CT) equipment, as reported on June 23, 2017, to the National Medical Products Administration (NMPA). The recall affects 28 units of various CT models, including Brilliance 64, Brilliance CT BigBore, Brilliance iCT, Brilliance iCT SP, and Ingenuity CT. The primary issue identified was inappropriate information displayed in the "Impressions" section of the calcification scoring report within the scanner operating software (versions 4.1.6, 4.2, 4.7.0, and 4.7.2). According to the instruction manual, this critical information should be located in the "Findings" section. This discrepancy could potentially lead to misinterpretation if users rely solely on the "Impressions" section for clinical evaluation. No injuries or deaths have been reported in connection with this issue. As a corrective action, Philips intends to directly communicate with all affected customers. They will provide detailed recall requirements and procedures, emphasizing the importance of adhering strictly to the equipment's instruction manual to ensure correct interpretation of calcification scoring reports. This action aims to mitigate any potential risk associated with the software display error.