China NMPA Product Recall - Patient monitor

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its Patient Monitor (Registration Certificate No.: 20163213268) on June 19, 2020, under the oversight of the National Medical Products Administration (NMPA). The recall stems from a critical firmware issue affecting the 866173 IntelliVue G7m anesthetic gas module. This flaw causes the device to erroneously detect a "premature failure" in its pump, even when the component is functional and presents no actual risk of failure. When this error occurs, the module ceases to measure and display crucial gas levels, including carbon dioxide, oxygen, and nitrous oxide. Users are then alerted by various technical or "INOP" alarms such as "GM component failure" or "inability to measure carbon dioxide," indicating a disruption in monitoring capabilities. These alarms are designed to prompt healthcare professionals to immediately switch to alternative anesthesia monitoring methods or locate a replacement anesthetic gas module to ensure continuous patient safety. The company is providing detailed information on affected product models, specifications, and batches through a "Medical Device Recall Event Report Form" to facilitate the recall process. This action underscores the company's commitment to product safety and compliance with regulatory standards.