China NMPA Product Recall - HeartStart XL+ Defibrillator/Monitor

On November 15, 2019, Philips (China) Investment Co., Ltd. announced a voluntary Class II recall concerning its HeartStart XL+ defibrillator/monitor products. This critical corrective action was reported within the regulatory framework of the National Medical Products Administration (NMPA), with specific reference to the Shanghai Food and Drug Administration's Medical Device Recall No. 2019-277. The core issue prompting this recall is the device's potential to fail to start, unexpectedly restart, or present a "Not Ready" status during self-testing when in standby mode. These malfunctions prevent the defibrillator/monitor from being immediately available for use, posing a significant risk of delaying urgent medical intervention for patients. To mitigate potential patient harm, Philips (China) Investment Co., Ltd. is undertaking this recall. Comprehensive details regarding the affected product models, specifications, and specific manufacturing batches are outlined in the accompanying "Medical Device Recall Event Report Form," ensuring transparency and enabling healthcare providers to identify and address impacted devices effectively.