China NMPA Product Recall - oxygen concentrator

On March 4, 2020, Philips (China) Investment Co., Ltd. announced a voluntary Class III recall concerning specific batches of its EverFlo oxygen concentrators, identified under Registration Certificate No.: 20162542389. This action stemmed from a discovery made during tests conducted by the National Medical Products Administration (NMPA) of China. The core issue involved a discrepancy between the stated and actual maximum audible sound levels of the device. The product's instruction manual indicated a maximum sound output of 43 dB(A); however, NMPA testing determined the actual sound level to be 48 dB(A). It is crucial to note that this deviation in sound level has been assessed as having no impact on the overall safety, effectiveness, or performance of the oxygen concentrators. Consequently, the NMPA concluded that there is no identified risk to patient health associated with this issue. Furthermore, Philips (China) Investment Co., Ltd. reported that a global monitoring of complaints has yielded no reports of related injury incidents to date. Operating under the regulatory framework of the NMPA and with information shared via the Shanghai Municipal Drug Administration, Philips initiated this voluntary recall. The required action involves the systematic recall of affected product models and batches, with comprehensive details provided in a specific "Medical Device Recall Event Report Form." This measure ensures transparency and adherence to regulatory standards despite the minimal health risk.