China NMPA Product Recall - Patient monitor

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its SureSigns VM series patient monitors, as reported by the National Medical Products Administration (NMPA) on March 18, 2021. The recall stems from a critical software issue identified in devices with software version A.02.63. The primary concern is the heart rate monitor's performance in pediatric mode. While the disclosed upper limit for newborn/pediatric mode is 350 bpm, the affected monitors have an internal upper display limit of 300 bpm. Consequently, when the electrocardiogram (ECG) input signal for a pediatric patient exceeds 300 bpm but remains below 350 bpm, the device displays a heart rate lower than the actual input. This discrepancy prevents the device's high heart rate alarm from activating, as the displayed value is below the measurement range's upper threshold. The failure of this crucial alarm poses a potential risk of delayed medical intervention for pediatric patients experiencing dangerously high heart rates. Philips (China) is undertaking this recall to address the non-conformance with safety requirements, providing further details on affected product models and batches in a Medical Device Recall Event Report Form. This action aligns with NMPA's medical device oversight.