China NMPA Product Recall - Body temperature controller

Bard Medical Technology (Shanghai) Co., Ltd., with Medivance Inc. as the manufacturer, initiated a voluntary Class II recall of its thermometers, as reported by the National Medical Products Administration (NMPA) on December 15, 2015. The core issue driving this recall is the presence of electronic components in affected products that can cause premature drainage or leakage of the internal control panel button battery. This battery is critical for maintaining system timing and static random access memory (SRAM). The primary risk identified is that such battery leakage could lead to the device becoming unresponsive upon system startup, compromising its function in detecting and controlling body temperature. The recall impacts products distributed globally across numerous regions, including China, the EU, U.S., and Japan, with 18 specific units in the Chinese market affected. In accordance with NMPA's regulatory requirements (SFDA(I)20122213086), Bard Medical Technology committed to dispatching technicians to customer locations worldwide. These technicians will evaluate the leakage current within the control panel battery circuit of potentially affected units. Should a high leakage current be detected, the control panel of the impacted device will be replaced to resolve the defect and ensure reliable operation.