China NMPA Product Recall - Monitor defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of specific monitored defibrillator models (M3535A, M3536A) in December 2014, as reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration. The recall was prompted by internal software defects identified on November 18, 2014. The primary issues stemmed from faulty software settings. Firstly, affected devices performed an automatic weekly test every hour, accelerating the degradation of treatment capacitors. Secondly, when connected to AC or DC power with no battery or a critically low battery charge (less than 10%), the Ready-to-Use (RFU) indicator would misleadingly display a black hourglass symbol, suggesting adequate power, rather than the expected low battery alert (flashing light and audio chirp). While other battery indicators functioned, this specific RFU anomaly posed a significant safety concern regarding device readiness. To address these critical malfunctions, Philips committed to providing free corrective actions for all affected devices globally, including 3 units imported to China. These actions involve replacing the compromised treatment capacitors and resetting the internal software settings. Philips representatives are actively contacting affected users to schedule and facilitate the necessary repairs, ensuring the devices return to their intended operational safety and reliability standards.