China NMPA Product Recall - Infusion pump

Changsha Biyang Medical Device Co., Ltd. initiated a Class III voluntary recall of its Infusion Pump, model BYS-820S, under the oversight of the National Medical Products Administration (NMPA). This recall, reported in September 2016 and published in July 2017, was prompted by several identified non-conformities affecting 50 manufactured/imported units, with 9 units sold in China. The primary issues included incorrect nameplate markings (requiring a change from a DC to an AC symbol), insufficient clarity in the instruction manual regarding functional grounding for the three-pin power socket (needing an upgrade to include the appropriate symbol), and an inadequate interval between the "low battery" alarm and the device stopping when operating on internal battery power. In response, Changsha Biyang Medical Device Co., Ltd. is undertaking corrective actions: modifying nameplate markings, revising the instruction manual to incorporate the functional grounding symbol, conducting individual testing of each unit, and adjusting machine parameters for those with inadequate battery discharge times. No customer complaints or adverse events related to these issues have been reported.