China NMPA Product Recall - Cold light source for medical endoscopes

Hefei Deming Electronics Co., Ltd. initiated a voluntary Class III recall for its medical endoscope cold light source, specifically product serial number 750210289. Publicized by the National Medical Products Administration (NMPA) on June 20, 2022, the recall addresses a significant non-compliance issue. The primary violation stems from the device's failure to meet the requirements of GB9706.1-2007, section 7.1, a national standard for the safety of medical electrical equipment. Specifically, when the rated input power was less than or equal to 100VA, a sampling test revealed a 42% deviation from the permissible +15% allowance, indicating a substantial concern regarding the device's electrical performance. In response, Hefei Deming Electronics Co., Ltd. is voluntarily recalling the affected devices, registered under Certificate No.:

皖械注准 20202060559. A Class III recall typically signifies that the product's use is not likely to cause adverse health consequences. Detailed information on affected models and batches is available in the associated "Medical Device Recall Event Report Form," emphasizing the company's commitment to product safety and regulatory adherence.