China NMPA Product Recall - HeartStart XL Defibrillator/Monitor

Philips (China) Investment Co., Ltd. initiated a Class II voluntary recall of its HeartStart XL defibrillator/monitor, as announced by the National Medical Products Administration (NMPA) on May 20, 2020. The recall addresses ongoing use of devices discontinued in February 2013, for which repair parts became unavailable in December 2018. Despite exceeding their service life, Philips discovered some customers were still utilizing these defibrillators. Continued operation of these outdated units presents a risk of malfunction in the energy selection knob switch, potentially leading to device failure to power on, inability to perform selected functions, or delivery of an incorrect energy level shock. These issues could result in delayed or ineffective patient treatment. Philips (China) is taking this action to mitigate the potential for unexpected device behavior once the product has surpassed its intended operational lifespan. Further details regarding the specific affected product models and batches are available in the associated Medical Device Recall Event Report Form.