China NMPA Product Recall - Monitor defibrillator

Philips (China) Investment Co., Ltd., on January 6, 2015, issued an expanded recall for its Monitored Defibrillators, models M3535A and M3536A, under the oversight of the National Medical Products Administration (NMPA) in China. This action stemmed from the identification of incorrect internal software settings affecting devices, including an additional unit brought into the recall scope. The primary issues identified were twofold: firstly, affected devices performed an automatic weekly test every hour, leading to accelerated degradation of the treatment capacitors. Secondly, the Ready-to-Use (RFU) indicator failed to accurately display a low battery warning when connected to AC or DC power with an absent or low-charge battery. Instead, it showed a misleading symbol suggesting sufficient power, potentially compromising device readiness. Philips is undertaking corrective actions for all identified units free of charge. These actions include replacing the treatment capacitors and resetting the internal software settings to rectify the issues. Philips representatives are in the process of contacting affected users to coordinate and facilitate these essential repairs, ensuring patient safety and device reliability.