China NMPA Product Recall - Electrocardiograph (ECG-2360)

Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Level III recall of its Electrocardiographs (ECG machines) and ECG meters, specifically model ECG-2360. This action, publicly announced by China's National Medical Products Administration (NMPA) on May 31, 2021, addresses a discrepancy found in the product's software. The primary issue identified was that the software release version number (02) on marketed units was inconsistent with the version (01) submitted during the initial product registration process. The company clarified that this was purely a version marking error, asserting that there are no actual differences in product function or performance between the two software iterations. Operating under the regulatory framework of the NMPA, the company is taking proactive steps to ensure compliance with its registered product information. This voluntary recall demonstrates the manufacturer's commitment to maintaining product consistency and regulatory adherence, even for issues that do not directly impact device safety or clinical efficacy. Further details on specific affected batches, models, and specifications are contained within the "Medical Device Recall Event Report Form" provided by the NMPA.