China NMPA Product Recall - Digital electrocardiograph

Guangzhou Sanrui Electronics Technology Co., Ltd. initiated a voluntary Level 3 recall for its digital electrocardiographs, as reported to the National Medical Products Administration (NMPA) on August 16, 2019, and published on September 2, 2019. The recall specifically targeted two units from batch 19KC034, model ECG-5512B. The primary issue was that these devices, while meeting the mandatory national standard YY 1139-2013 for "input dynamic range," did not conform to the company's own internal product technical requirements (item 2.2.3).

The company confirmed that this was an isolated incident, had not resulted in any customer complaints or adverse event reports, and did not pose a safety risk or compromise device performance. In response, Guangzhou Sanrui Electronics Technology Co., Ltd. undertook several corrective actions: immediately notifying customers to recall the affected batch, conducting random inspections of all other digital electrocardiograph models in inventory and on the production line (which were found compliant), and analyzing the recalled products to verify the isolated nature of the deviation.