# China NMPA Product Recall - Monitor/Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/974e6f7c-e476-4485-b36b-acdb5164ea59/
Source feed: China

> China NMPA product recall for Monitor/Defibrillator by Philips (China) Investment Co., Ltd. published July 29, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its HeartStart MRx Mon

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of its Monitor/Defibrillator devices.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-07-29
- Product Name: Monitor/Defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: The HeartStart MRx monitor defibrillator's energy selection switch, controlled by the energy knob, is used to turn on the HeartStart MRx monitor defibrillator, set it to the desired mode, and select the energy setting. The energy switch may malfunction, causing the device to exhibit the following behaviors: the device may fail to perform the selected function; the energy knob may not be able to be changed to the selected energy setting; the device may not deliver shocks at the energy level corresponding to the user's selected settings. These device behaviors may result in treatment delays or failure to provide the intended treatment.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its HeartStart MRx Monitor/Defibrillator, publicly announced on July 29, 2020, under the oversight of the National Medical Products Administration (NMPA). The recall addresses a critical malfunction in the device's energy selection switch, which controls power, mode, and energy settings. This defect can prevent the defibrillator from performing selected functions, changing energy settings, or delivering shocks at the user-specified energy level. Such issues pose a significant risk, potentially causing treatment delays or a complete failure to deliver essential therapy. The company's action, documented internally as FCO86100212, reflects its adherence to the NMPA's regulatory framework and its commitment to patient safety. The recall requires the removal of all affected devices from circulation, with specific details on models, specifications, and batches available in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/