China NMPA Product Recall - Patient monitor (models: B20, B30)

GE Healthcare (China) Co., Ltd. initiated a Class I voluntary recall for specific patient monitor models (B20, B30) and their associated gas and end-tidal carbon dioxide modules (E-MINIC, N-FC, N-FCREC). This action, reported to the National Medical Products Administration (NMPA) on August 13, 2014, and internally dated July 21, 2014, addresses a critical safety concern. The primary issue is a malfunction in the CO2 detectors within these modules, which may cause a slow and continuous decrease in Et-/FiCO2 measurement values. This defect leads to inaccurate readings that could significantly impact clinical decisions for both mechanically and spontaneously ventilated patients. The recall affects approximately 196 units sold in China and potentially other global regions. As required actions, GE Healthcare instructed customers to conduct a self-check of their products. If a malfunction is identified, users are directed to immediately stop using the device and contact technical support or a local service representative. GE Healthcare has committed to correcting this problem free of charge, prioritizing patient safety and device integrity.