China NMPA Product Recall - Image archiving and transmission system, image archiving and transmission software

GE Healthcare Trading Development (Shanghai) Co., Ltd., representing manufacturer GE Healthcare, initiated a voluntary recall of specific image archiving and transmission systems and software, as announced by the National Medical Products Administration (NMPA) on March 11, 2021. The primary concern is a potential for lost image sequences during image acquisition in particular models and batches of these devices. The affected products include image archiving and transmission systems (Registration No.: CFDA (Imported) 2014 No. 2702186) and image archiving and transmission software (Registration No.: CFDA Import Registration 20182701756). This recall has been classified as Level II. GE Healthcare's action, under NMPA oversight, requires the company to address this product deficiency by providing detailed information on affected models, specifications, and batches in a "Medical Device Recall Event Report Form." This proactive measure reflects the company's commitment to product safety and regulatory compliance, with further specifics detailed in the attached recall report for impacted users.