China NMPA Product Recall - Positron emission tomography and X-ray computed tomography imaging system

On August 27, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. proactively initiated a voluntary Class II recall concerning specific models of its PET/CT and PET/X-ray computed tomography imaging systems. This significant regulatory action was overseen by China's National Medical Products Administration (NMPA) and specifically issued by the Shanghai Food and Drug Administration (Shanghai 2019-207). The primary safety concern prompting this recall involves a technical malfunction within the affected scanners: while the scanning process may stop, the X-ray exposure continues for the entirety of the preset CT scan time. This critical flaw carries the risk of inadvertently exposing patients to additional, unnecessary X-ray radiation at a localized anatomical area, potentially compromising patient safety during diagnostic procedures. The company has identified several affected product lines, marked by registration certificate numbers such as 国械注进20153331399 and others. As part of this comprehensive recall, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. requires a thorough review, with detailed information regarding specific models, specifications, and batch numbers made available through a "Medical Device Recall Event Report Form." This voluntary action underscores the manufacturer's responsibility in maintaining product safety standards under the stringent regulatory framework.