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

Siemens Healthineers, Inc. has initiated a voluntary Class III recall of specific positron emission tomography (PET) and computed tomography (CT) systems, as announced by the National Medical Products Administration (NMPA) on February 21, 2023. This action stems from an identified issue with the locking mechanism in certain product models and batches. The primary concern is that under strong external force, the frame of these medical devices may experience movement or even tip over, posing a potential safety risk. The recall encompasses several models of these advanced imaging systems, identified by Registration Certificate Nos. 20173061250, 20173060106, 20173062264, 20203060324, and 20203060518. Siemens Healthineers is taking this measure to address the product defect and ensure patient safety and device reliability. As per the NMPA's regulatory oversight, detailed information concerning the exact models, specifications, and affected product batches is available in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to quality control and adherence to regulatory standards established by the NMPA, proactively mitigating potential risks associated with the identified mechanical issue.