China NMPA Product Recall - oxygen concentrator

Philips (China) Investment Co., Ltd. initiated a Class III voluntary recall of its oxygen concentrators, as announced by the National Medical Products Administration (NMPA) on November 13, 2017. The primary issue identified was that the Chinese labels on the affected products were not updated promptly after the company secured new product registration certificates. This lack of timely label revision constituted a non-compliance with regulatory requirements related to medical device labeling.

Under the oversight of the NMPA, the regulatory body responsible for medical devices in China, Philips (China) proactively reported this discrepancy. The recall, categorized as Class III, indicates a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences.

As a result of this finding, Philips (China) was required to undertake a voluntary recall of the impacted oxygen concentrator units. Specific details regarding the models, specifications, and batches involved were provided in the accompanying "Medical Device Recall Event Report Form." This action ensures that all distributed products adhere to current labeling standards mandated by the NMPA, maintaining product safety and regulatory compliance within the Chinese market.