China NMPA Product Recall - Patient Data Module (PDM)

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II medical device recall on June 28, 2021, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall addresses a critical safety issue with Patient Data Modules (PDMs) utilizing Masimo SET technology, which are integrated into their patient monitors. The core problem arises when these PDMs are not fully powered off for periods exceeding two years, leading to the display of inaccurate, frozen SpO2 oxygen saturation values. This malfunction means the reported values do not reflect the patient's actual clinical status. The primary concern is the potential for missed SpO2 alarms, which could severely delay the diagnosis and subsequent treatment of conditions such as hypoxia or hyperxia, posing a significant risk to patient safety. The recall specifically targets the affected PDM units within various patient monitor models, identified by multiple CFDA Import Registration Numbers. Further detailed information regarding the specific models, specifications, and affected batches is available in the "Medical Device Recall Event Report Form." This proactive measure by GE Healthcare aims to mitigate potential harm and ensure the reliability of their patient monitoring systems in clinical settings.