China NMPA Product Recall - Monitor/Defibrillator

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its HeartStart MRx Monitor/Defibrillator, as announced on July 1, 2019, by the National Medical Products Administration (NMPA). The recall stems from a critical issue identified with the AC power module (model M3539A). This module's failure can lead to the entire device becoming inoperable if the lithium-ion battery (model M3538A) is not properly installed according to device instructions, or if the AC mains power is interrupted. The primary concern is that a malfunctioning AC power module may not only fail to power the device but also be unable to charge the battery. Consequently, in situations where both battery power and AC power are simultaneously lost, patients could experience interruptions in monitoring or critical delays in receiving defibrillation shocks or pacing treatments. This poses a significant safety risk in emergency medical situations. Operating under the oversight of the NMPA, and registered with the Shanghai Food and Drug Administration, Philips (China) is taking this action to address the potential hazard. The company is recalling specific units of the HeartStart MRx Monitor/Defibrillator (Registration Certificate No.: 20163214004). Further comprehensive details regarding affected product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" provided by the company.