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 Systems, including Biograph mCTS, Biograph mCTX, and Biograph mCT Flow models. The company reported this issue to the National Medical Products Administration (NMPA) on December 15, 2016, with the NMPA publishing the recall on February 21, 2017. The primary concern stems from the laser positioning light window on the system's front cover, which may become loose or detached.

This defect poses a potential safety risk: users could inadvertently come into contact with internal electrical or rotating components of the system if the window is compromised, potentially leading to serious injuries such as electric shock or physical harm. While no user complaints had been reported, Siemens Healthineers identified this hazard.

In response, Siemens Healthineers, operating under NMPA's regulatory framework, is issuing customer notification letters (MI516/16/S) to inform users of the identified risk and preventive measures. Affected customers are instructed to immediately discontinue use of the equipment if they discover a missing or loose laser positioning light window and to contact their local Siemens customer service engineer for necessary repairs. The recall impacts 31 units sold in China and other global regions.