China NMPA Product Recall - LIFEPAK 15

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Physio-Control, Inc. for its LIFEPAK 15 Defibrillator/Monitoring System. The recall, reported on October 18, 2016, and publicly announced on November 29, 2016, addresses a critical display issue. Managed in China by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., the issue pertains to the end-tidal carbon dioxide (EtCO2) monitoring function when the device uses kPa or % settings and the reading exceeds 9.9. In such cases, the first digit of the EtCO2 value may be partially obscured, potentially leading clinicians to misinterpret a high reading as low, which could result in incorrect patient treatment. While this poses a risk, no instances of patient harm have been reported due to this specific issue. The device is registered under CFDA (Imported) 2012 No. 3212890. Required actions include disseminating this recall information to all global distributors and users. Users are advised to carefully monitor both the EtCO2 waveform and the displayed range, activate EtCO2 alarms, and consider changing the unit setting to mmHg as an interim measure. Physio-Control, Inc. is committed to releasing a software update on its official website and will notify users to apply the update once it becomes available to permanently resolve the display anomaly.