# China NMPA Product Recall - External defibrillator monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-kincoway-shenzhen-industrial-co-ltd/b1f53d53-08ca-46e9-8296-5e682dd441fd/
Source feed: China

> China NMPA product recall for External defibrillator monitor by Philips Kincoway (Shenzhen) Industrial Co., Ltd. published April 19, 2021. Recall level: Level 2 Recall. Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its Efficia D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Kinco (Shenzhen) Industrial Co., Ltd. voluntarily recalls external defibrillator monitors.
- Company Name: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Publication Date: 2021-04-19
- Product Name: External defibrillator monitor
- Recall Level: Level 2 Recall
- Recall Reason: The Efficia DFM100 external defibrillator may issue a low battery warning due to voltage surges when inserting or removing the battery. This warning may delay or prevent treatment from being delivered.
- Discovering Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Manufacturing Company: Philips Kincoway (Shenzhen) Industrial Co., Ltd.
- Summary: Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its Efficia DFM100 external defibrillator monitors, as announced by the National Medical Products Administration (NMPA) on April 19, 2021. The recall stems from the company's discovery that the device may generate a low battery warning due to voltage surges occurring during battery insertion or removal. This critical issue poses a risk of delaying or preventing essential medical treatment for patients. The affected devices carry Registration Certificate No.: 20183080392. While the document does not specify inspection dates, the recall was voluntarily initiated by Philips Kinco upon identification of the defect. The NMPA's involvement highlights its role in overseeing medical device safety and public health, operating under a framework that requires manufacturers to address product deficiencies. As part of the corrective actions, Philips Kinco (Shenzhen) Industrial Co., Ltd. is recalling the specified models. Further details regarding the affected product models, specifications, and serial numbers are available in the accompanying "Medical Device Recall Event Report Form" and multiple appendices listing affected domestic units. This proactive measure aims to mitigate potential patient harm and ensure the reliability of these life-saving medical devices.

Company: https://www.globalkeysolutions.net/companies/philips-kincoway-shenzhen-industrial-co-ltd/fe26b37f-e114-43d2-b1a3-85beed6a47a7/