China NMPA Product Recall - Operating table system

Maikewei (Shanghai) Medical Equipment Co., Ltd., the Chinese responsible unit for MAQUET GmbH, initiated a voluntary Level III recall of its Operating Table System's accessory adapters. The recall, reported on August 12, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, stemmed from a post-market complaint regarding material failure. Investigations confirmed that the materials used in accessory adapters (model 1180.10A0, part 600525A0), manufactured since 2002, did not meet Maquet's internal specifications for stiffness, flexibility, and overall design strength, potentially affecting patient safety. Although no personal injuries were reported, the company acted preventatively to enhance medical device safety. The NMPA-indexed recall (JGXX-2016-10411) affects three units imported into China. Required actions include issuing a "User Safety Notice" to customers, instructing them to cease using the faulty adapters, and providing free replacements for all affected accessory adapters globally.