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

Siemens Healthineers initiated a voluntary Class II recall for its Positron Emission Tomography and X-ray Computed Tomography (PET/CT) Systems, specifically models Biograph mCT.S and Biograph mCT.X. The company reported this action on December 15, 2016, and China's National Medical Products Administration (NMPA) published the recall notice on February 21, 2017. The core issue is that the laser positioning light window, a component integrated into the front cover of the affected systems, may become loose or detach. This defect creates a safety hazard, as it could expose personnel to internal electrical or rotating parts of the system, potentially leading to serious injuries like electric shock or physical trauma. Although no user complaints were reported at the time, Siemens proactively addressed this potential risk. As a required action under NMPA's regulatory framework, Siemens Healthineers is sending a customer notification letter (MI516/16/S) to inform users about the risk and outline avoidance measures. Customers are instructed to immediately cease using any Biograph mCT or Biograph mCT Flow system with a missing or loose laser positioning light window and to contact Siemens customer service for corrective repair. The recall involves 31 units sold in China.