China NMPA Product Recall - SureSigns VM 4, SureSigns VM 6 Patient Monitors

Philips Kinco (Shenzhen) Industrial Co., Ltd. has initiated a voluntary Level II recall for its SureSigns VM 4 and SureSigns VM 6 patient monitors. The recall, reported on March 29, 2021, addresses a significant safety concern identified in these devices. The primary issue arises when the patient monitors are utilized in pediatric mode. If the electrocardiogram (ECG) input signal surpasses 300 beats per minute (bpm), the device's display incorrectly shows a heart rate below this upper limit. Critically, the alarm system designed to alert medical professionals to such high input signals fails to activate under these specific conditions. This malfunction poses a potential risk, as healthcare providers may not receive timely warnings about dangerously elevated heart rates in pediatric patients, which could lead to delayed or inappropriate clinical interventions. This action is being overseen by the National Medical Products Administration (NMPA) in China, reflecting the regulatory oversight of medical devices. Philips Kinco (Shenzhen) Industrial Co., Ltd. is undertaking this recall to ensure patient safety and device integrity. Specific details regarding the affected product batches are available in the associated "Medical Device Recall Event Report Form."