# China NMPA Product Recall - Monitor/Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/f878d723-70fe-4758-a704-bbfd7f47394d/
Source feed: China

> China NMPA product recall for Monitor/Defibrillator by Philips (China) Investment Co., Ltd. published May 22, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its HeartStart MRx Mo

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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: 2020-05-22
- Product Name: Monitor/Defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: The HeartStart MRx monitors/defibrillators involved in the product were not included in the previous field procedures due to an error, which may have resulted in the affected products not receiving many of the necessary corrective actions, potentially leading to treatment delays or failure to provide the expected treatment.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its HeartStart MRx Monitor/Defibrillator, as reported by the National Medical Products Administration (NMPA) on May 22, 2020. The company's internal monitoring identified that a specific range of these medical devices were inadvertently excluded from previous field procedures. Consequently, these affected HeartStart MRx units may not have undergone essential corrective actions that were mandated. This oversight presents a significant risk, potentially leading to critical delays in patient treatment or the complete failure to deliver the anticipated medical intervention when the defibrillator is needed. Philips (China) has therefore undertaken this recall to address the potential safety concerns arising from the unperformed corrective measures. While the general nature of the issue involves omitted maintenance, specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action aligns with the NMPA's regulatory oversight to ensure the safety and efficacy of medical devices within China.

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