China NMPA Product Recall - Ventilator

On July 6, 2020, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its ventilators (Registration Certificate No.: 国械注进20152541271), as reported to the National Medical Products Administration (NMPA). This action was prompted by several identified product deficiencies concerning the Philips OmniLab Advanced+ device, indicating non-compliance with established product standards. The main issues included a missing "fresh gas inhalation" label within the device's identification system. Additionally, the device instructions were found to be incomplete, lacking crucial technical specifications such as the noise sound pressure level, the maximum flow rate at a specific pressure, and the pressure/volume curve. Under the regulatory oversight of the NMPA, Philips (China) is undertaking this recall to rectify these non-conformities. The company is required to furnish comprehensive details, including specific models, specifications, and batch numbers of the affected products, in a dedicated "Medical Device Recall Event Report Form" to ensure an effective recall process. This measure underscores the company's commitment to product safety and adherence to regulatory mandates in the medical device sector.