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

Siemens Healthineers initiated a voluntary Class II medical device recall, publicized by the National Medical Products Administration (NMPA) on February 21, 2017, following an internal report dated December 15, 2016. The recall involves their Positron Emission Tomography and X-ray Computed Tomography Systems, specifically models Biograph mCT and Biograph mCT Flow, with 31 units sold in China originating from the USA. The primary issue identified is that the laser positioning light window, integrated into the system's front cover, may become loose or detach. This structural defect presents a potential safety hazard: personnel could inadvertently come into contact with internal electrical or rotating components of the system's gantry if they reach into the compromised window. Such contact carries a serious risk of injury, including electric shock or physical trauma. Under the NMPA's regulatory oversight, Siemens Healthineers is implementing corrective actions. These include issuing a customer notification letter (MI516/16/S) to inform users about the identified risk and outline necessary precautions. Furthermore, affected customers are instructed to immediately cease using any Biograph mCT or Biograph mCT Flow system exhibiting a loose or missing laser positioning light window and to contact Siemens customer service for prompt repair. This ensures user safety and compliance with medical device standards.