China NMPA Product Recall - Image archiving and transmission software

GE Healthcare Trading Development (Shanghai) Co., Ltd., representing its manufacturer GE Healthcare, has initiated a voluntary Level II recall for its image archiving and transmission software. This action was officially reported to the National Medical Products Administration (NMPA) on December 20, 2023. The primary reason for the recall stems from a significant operational issue where the affected software may not properly close when running on Workflow Manager and Universal Viewer platforms. This malfunction could potentially disrupt the efficient management and viewing of medical images, thereby impacting clinical workflows. The recall is conducted under the NMPA's regulatory framework, as indicated by National Medical Device Registration Certificate No. 20182701756. A Level II recall suggests that while the use of the product may cause temporary or reversible adverse health consequences, the probability of serious adverse consequences is considered remote. GE Healthcare has directed stakeholders to the 'Medical Device Recall Event Report Form' for comprehensive details regarding the specific affected product models and the scope of this important recall action.