China NMPA Product Recall - Medical oxygen concentrator

Chongqing Aerospace Rocket Electronic Technology Co., Ltd. initiated a voluntary recall of its Medical Oxygen Concentrators (Model YQ-531 (Crane), registration no. 渝食药监械（准）字2014第2540143) on December 11, 2019, with the National Medical Products Administration (NMPA) publishing the event on January 15, 2020. This action followed a random inspection in Chongqing that revealed significant product defects. The concentrators failed to meet several critical technical requirements for product registration, specifically Clauses 1.6.1.a, 1.6.1.h, 1.6.1.n, 1.6.1.y, 2.6.3.f, 2.6.3.g, and 22.1.7.2 of the YY0732-2009 standard. These violations indicate non-compliance with established product safety and performance criteria. Operating under national medical device recall regulations, the company is recalling one batch, comprising three units, of the affected devices sold in mainland China. The required actions involve issuing formal recall notices and implementing immediate improvements to address the identified non-conformities, ensuring future compliance and product safety. This recall is categorized as Level III, signifying a situation where the use or exposure to the non-compliant product is unlikely to cause adverse health consequences.