China NMPA Product Recall - Medical angiography X-ray machine

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) via a notice from the Shanghai Municipal Drug Administration on May 19, 2021. The recall addresses a significant product defect discovered by GE Healthcare affecting certain IGS systems manufactured between February 2020 and March 2021. These devices exhibited a critical malfunction where the real-time display image was split by a vertical line, resulting in two distinct images of varying sizes. Furthermore, the images showed erratic horizontal movement within the display screen, potentially compromising diagnostic accuracy and patient safety during medical procedures. This action falls under the regulatory oversight of the NMPA, which ensures the safety and efficacy of medical devices in China. The Class II recall designation indicates that the 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 highlights the company's commitment to product quality and patient safety, aligning with regulatory expectations for addressing identified device non-conformities. Detailed information regarding specific affected models and batches is available in the associated "Medical Device Recall Event Report Form."