China NMPA Product Recall - Dynamic electrocardiogram workstation

Shenzhen Mindray Medical Instruments Co., Ltd. initiated a voluntary Class III recall for specific Holter monitor workstations (Dynamic Electrocardiogram Workstation, Registration Certificate No.: 粤食药监械（准）字2014第2210436号). This recall, reported to the National Medical Products Administration (NMPA) on May 20, 2019, and published on May 22, 2019, addresses a significant software anomaly. The primary issue identified in versions V1.22 and V1.23 of the PC-side analysis software is waveform distortion. This occurs specifically when the power frequency filter function, which is typically off by default, is intentionally enabled. The affected products include models SE-2012 and SE-2003, with 182 units sold in China and others distributed across various regions globally, including the EU, USA, Latin America, Africa, Asia Pacific, and the Middle East. Mindray stated that no patient harm or adverse events have been reported due to this issue. As immediate corrective actions, the company has issued recall notices to customers. These notices instruct users of the affected software versions (V1.22 and V1.23) to refrain from activating the power frequency filter. Furthermore, Mindray is committed to supplying affected customers with unaffected recorder versions of the Holter ECG workstation to mitigate the identified risk. This action ensures patient safety while preventing potential misdiagnoses arising from distorted electrocardiogram readings.