# China NMPA Product Recall - Defibrillation/monitoring system

Source: https://www.globalkeysolutions.net/records/china_product_recall/phytoconcile-shanghai-medical-devices-co-ltd/7dc6c8a8-e201-4bf9-90f2-7b2dd808cfa9/
Source feed: China

> China NMPA product recall for Defibrillation/monitoring system by Phytoconcile (Shanghai) Medical Devices Co., Ltd. published March 03, 2020. Recall level: Level 2 Recall. On March 3, 2020, the National Medical Products Administration (NMPA) announced a Level II voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Phison Medical (Shanghai) Co., Ltd. is voluntarily recalling its defibrillator/monitoring system.
- Company Name: Phytoconcile (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2020-03-03
- Product Name: Defibrillation/monitoring system
- Recall Level: Level 2 Recall
- Recall Reason: On some Lifpak 15 defibrillator/monitoring systems, the "shock" button may oxidize over time, so it may not deliver a defibrillation shock after the button is pressed.
- Discovering Company: Phytoconcile (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Phytoconcile (Shanghai) Medical Devices Co., Ltd.
- Summary: On March 3, 2020, the National Medical Products Administration (NMPA) announced a Level II voluntary recall initiated by Phisonconcile (Shanghai) Medical Devices Co., Ltd. The recall pertains to specific LIFEPAK 15 defibrillation/monitoring systems due to a significant safety concern. The core issue identified is the potential for oxidation inside the main 'shock' button, which could prevent the device from delivering a defibrillation shock when pressed. Importantly, the 'shock' button located on the defibrillator handle is not affected by this problem. Phisonconcile (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling the affected systems, registered under CFDA (Imported) 2012 No. 3212890 (Revised). This action is taken to ensure the reliability and safety of the medical devices. Further detailed information, including specific product models, specifications, and batch/serial numbers, is available in the associated Medical Device Recall Event Report Form, which provides comprehensive data for identifying affected units and facilitating proper retrieval.

Company: https://www.globalkeysolutions.net/companies/phytoconcile-shanghai-medical-devices-co-ltd/6c01e0dc-f32f-4e25-bfb5-fde89a99be92/