China NMPA Product Recall - ECG information management software

On July 27, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. The recall pertains to the company's ECG information management software, specifically product model QP-620MC, which is regulated under the NMPA framework, with details also provided by the Shanghai Municipal Drug Administration. The reason for the recall stems from a software design modification that led to a discrepancy in version numbering. While the complete software version was updated from V1.0.001 to V1.0.001.01, this change was inconsistent with the product technical requirements' 'version naming rules,' which specify a VX.Y.Z format, with an initial version of V1.0.000. It is crucial to note that this issue is solely related to an incorrect software version marking. The company explicitly stated that the software's effectiveness and security remain uncompromised. As a required action, Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. voluntarily recalled the affected ECG information management software. Further specific information regarding the affected product models, specifications, and batches is accessible through the 'Medical Device Recall Event Report Form' attachment.