China NMPA Product Recall - Electric hospital bed

ArjoHuntleigh AB (Sweden) has initiated a voluntary Class II recall of its electric hospital beds, identified by National Medical Device Registration Number: 20182150175. This recall, reported by Junjieyou (Suzhou) Medical Equipment Trading Co., Ltd. and published by the National Medical Products Administration (NMPA) on September 6, 2023, addresses potential malfunctions within the IndiGo (Intuitive Drive Assist) system of the affected beds. The primary issue is a potential operational flaw in the IndiGo system, which could impact the intended functionality of these medical devices. A Class II recall under the NMPA's regulatory framework indicates that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. ArjoHuntleigh AB (Sweden) is undertaking this voluntary action to mitigate any potential risks associated with the identified malfunction. Detailed information regarding the models, specifications, and batch numbers of the affected products is available in the