China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (CT) system

The National Medical Products Administration (NMPA) reported on June 21, 2019, that Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for its Positron Emission Tomography and X-ray Computed Tomography System, specifically the Vereos system. The recall stems from identified manufacturing concerns regarding the alignment and potential gaps in the device's front and rear covers. These issues could cause the edges of the covers to protrude into the system's aperture, potentially affecting device integrity or operation. Philips (China) submitted a "Medical Device Recall Event Report Form" to detail the specific models, specifications, and batches involved in this corrective action. This voluntary recall demonstrates the company's commitment to product safety and compliance under the NMPA's regulatory framework, which oversees medical device standards in China. The Class III designation indicates a situation where the probability of adverse health consequences from product use is low, emphasizing a proactive measure to maintain device quality.