China NMPA Product Recall - G30/G40 Patient Monitor

Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Level II recall for its G30/G40 patient monitors. This action, published by the National Medical Products Administration (NMPA) on March 29, 2021, addresses a critical safety concern identified with the devices. The primary issue arises when the patient monitors are used in pediatric and neonatal modes. If the electrocardiogram (ECG) input signal surpasses 300 beats per minute (bpm), the device's displayed heart rate registers below its specified 300 bpm threshold. Critically, this inaccuracy prevents the device's alarm system from activating for such high-frequency input signals. The failure of the alarm system poses a significant risk, particularly for vulnerable patient populations where accurate and timely heart rate monitoring is paramount. The regulatory oversight for this recall falls under the NMPA, with details being disseminated via the Guangdong Provincial Drug Administration Website. Philips Kinco (Shenzhen) Industrial Co., Ltd. is voluntarily recalling the affected patient monitors to rectify this defect. Specific product models and further details regarding the scope of the recall are documented in an accompanying 'Medical Device Recall Event Report Form'.