China NMPA Product Recall - X-ray computed tomography equipment

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its X-ray Computed Tomography (CT) equipment, as reported by the National Medical Products Administration (NMPA) on May 8, 2017. The recall stems from a critical issue identified where, during retrospective respiratory phylogenetic 4D CT scans utilizing the Bellows hilum device, CT images were potentially reconstructed in monophasic mode. A significant concern was the accompanying incorrect annotation on these images, falsely indicating specific phases ranging from 0% to 90%.

This technical malfunction poses a risk of misinterpretation during diagnostic imaging, potentially affecting patient care and medical assessment. The company proactively reported this finding, leading to the decision to recall the affected products. A Class III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information regarding the specific models, specifications, and batches of the impacted CT equipment is available in the "Medical Device Recall Event Report Form" associated with this announcement. Philips (China) Investment Co., Ltd. is responsible for addressing this issue under the NMPA's regulatory oversight.