China NMPA Product Recall - Central monitoring workstation セントララモニタ

Nippon Kogaku Kogyo Co., Ltd. initiated a voluntary Class 3 recall of its Central Monitoring Workstation (Central Monolithic Station) on September 18, 2021. This action was reported to the National Medical Products Administration (NMPA) by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. The recall stems from a critical software defect in specific product models and batches. Following a software upgrade to version 05-19, users have reported that clicking on the trend list within the inpatient review window causes the device to emit a sound and automatically restart. The manufacturer is undertaking this voluntary recall to address the performance issue. Detailed information regarding the specific product models, specifications, and batches affected by this recall is available in the accompanying "Medical Device Recall Event Report Form" attachment.