China NMPA Product Recall - Image archiving and transmission software

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its image archiving and transmission software, as officially reported by the National Medical Products Administration (NMPA) on January 6, 2020. This decisive action follows the discovery of a critical software anomaly. The core issue involves medical images, specifically those from examination series with diverse pixel dimensions, which may exhibit inaccurate display characteristics when saved and later reviewed using the DICOM grayscale display mode (GSPS). This defect compromises the integrity and reliability of diagnostic images, potentially impacting patient care. The affected product operates under Registration Certificate No. 20182701756, signifying its regulatory approval status. This voluntary recall, categorized as Level II, indicates a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. GE Healthcare's proactive measure aims to rectify this display inaccuracy and uphold patient safety. Comprehensive details pertaining to the specific product models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form" accompanying the NMPA announcement. This recall highlights the manufacturer's responsibility under the NMPA framework to address product deficiencies promptly.