China NMPA Product Recall - Carbon dioxide laser therapy device

In October 2018, Shanghai Jiading Optoelectronic Instrument Co., Ltd. announced a voluntary Class III recall of its Carbon Dioxide Laser Therapy Device, a measure overseen by the National Medical Products Administration (NMPA). The company initiated this recall after discovering two significant deviations in product performance. Firstly, the actual laser value on the device's working surface was found to be potentially lower than the established set value. Secondly, the measured actual wavelength did not meet the required product standard specifications. These discrepancies are critical as they can compromise the device's efficacy and potentially affect patient treatment outcomes, indicating a failure to consistently meet its design and regulatory performance criteria. The recall encompasses specific models, specifications, and batches of the device, with comprehensive details provided in the "Medical Device Recall Event Report Form" issued by the company. This proactive step by Shanghai Jiading Optoelectronic Instrument Co., Ltd. highlights its responsibility to address product quality and safety concerns, ensuring adherence to NMPA's regulatory framework and maintaining public trust in medical devices. The Class III classification indicates that the product defect is unlikely to cause adverse health consequences, but correction is still necessary for product integrity.