China NMPA Product Recall - IntelliVue Patient Monitor MX400/MX450; IntelliVue Patient Monitor MX500/MX550
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Philips Medizin Systeme Boeblingen GmbH has initiated a voluntary Class III recall for certain IntelliVue Patient Monitors, specifically models MX400/MX450 and MX500/MX550. This recall, announced by the National Medical Products Administration (NMPA) on July 2, 2025, stems from a critical technical issue: the monitors fail to display a "No Device Data" reminder message when disconnected from a Hamilton ventilator. This omission could potentially lead to user confusion or a lack of awareness regarding the device's operational status. The affected products include devices with National Medical Device Registration Certificates 20193072217 and 20193072216. Philips (China) Investment Co., Ltd. reported this issue, leading to the manufacturer-initiated recall. It is important to note that the specific models and batches involved in this recall were not imported into China. The recall report further details the specific models, specifications, and batches. This action underscores the company's commitment to product safety and compliance with regulatory standards overseen by the NMPA, despite the limited scope of affected regions for this particular recall.
ID · e71d4d62-605c-4e38-87c0-64b165165877