China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (models: Biograph mCTS, Biograph mCTX)

Siemens Healthineers initiated a voluntary Class II recall of its Positron Emission Tomography and X-ray Computed Tomography Systems, specifically Biograph mCTS and Biograph mCTX models. This recall, published by the National Medical Products Administration (NMPA) on March 1, 2017, with an initial report date of December 15, 2016, addresses a critical safety concern. The main issue identified is that the laser positioning light window, integrated into the front cover of these medical imaging systems, may become loose or detach. This detachment poses a significant risk, as it could allow personnel to inadvertently contact internal electrical or rotating components, potentially leading to serious injuries such as electric shock or physical harm. Under the NMPA's regulatory framework, the company's required actions involve issuing a customer notification letter (MI516/16/S) to inform users of the identified risk and preventive measures. Furthermore, customers are explicitly instructed that if a laser positioning light window is found to be missing or loose, they must immediately cease using the Biograph mCT or Biograph mCT Flow system and contact their local Siemens customer service engineer for corrective action. The recall impacts 31 units sold in various regions, including China.