China NMPA Product Recall - Patient monitor

On August 12, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Philips (China) Investment Co., Ltd., on behalf of its manufacturer, Philips Medical Systems. This recall pertains to specific patient monitors (Registration Certificate No.: Guowang 20153212166) which are regulated under the NMPA's stringent medical device framework. The core issue prompting this recall is a potential manufacturing defect where the connector thickness in the affected patient monitors was found to exceed specified design values. This deviation could potentially impact the device's functionality or safety. As a required action under the NMPA’s regulatory oversight, Philips Medical Systems is conducting a voluntary recall to address this non-conformance. The official recall notification, indexed as JGXX-2019-10524, directs stakeholders to a detailed 'Medical Device Recall Event Report Form' for comprehensive information regarding the specific models, specifications, and batches of patient monitors impacted by this corrective measure. The company is responsible for ensuring the safe removal or remediation of these devices from the market to uphold patient safety standards.