China NMPA Product Recall - Whole-body X-ray computed tomography system

On July 8, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its whole-body X-ray computed tomography system, specifically certain Revolution CT scanning equipment. This action was taken due to a potential problem that could lead to additional low-dose radiation exposure for patients. The National Medical Products Administration (NMPA) oversaw this regulatory action, which was also reported to the Shanghai Food and Drug Administration under Medical Device Registration Certificate No. 2019-160. While specific inspection dates were not detailed, the company proactively reported the defect. The core issue involves a potential malfunction within the CT scanning equipment, which could result in unintended radiation exposure beyond standard levels. As a Class III recall, the regulatory framework signifies that the identified issue is unlikely to cause severe adverse health consequences. The required action involves the company actively removing the affected products from use to mitigate any potential risks to patients and ensure device safety. Further specifics on affected models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form.