China NMPA Product Recall - Dental light curing machine

DENTLIGHT INC. has initiated a voluntary Class III recall of its Dental Cure-Intensive Light (DILI) machines (Registration No.: 20162551854). This action follows findings from a 2018 national random inspection. The inspection revealed two primary compliance issues with the medical devices. Firstly, the external markings on the DILI machines or their components were found to be non-compliant with the requirements outlined in GB9706.1-2017, a standard for Medical Electrical Equipment Safety. Secondly, testing at operating temperature showed the continuous leakage current and patient auxiliary current measurement value to be 0.136mA. This measurement exceeded the maximum allowable limit of 0.1mA, as specified in Table 4 of the same GB9706.1 standard. In response to these significant safety and compliance deviations, DENTLIGHT INC. is undertaking this recall in accordance with the National Medical Products Administration's (NMPA) "Regulations on the Recall of Medical Devices." Affected models, specifications, and batches are detailed in the "Medical Device Recall Form." This recall emphasizes the importance of adherence to national safety standards for medical electrical equipment to ensure patient safety and product reliability.