# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/475a7a42-3a1b-4921-bace-64b21874e748/
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published November 07, 2018. Recall level: Level 2 Recall. Philips Medical Systems, in conjunction with its agent Philips (China) Investment Co., Ltd., initiat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems initiates voluntary recall of monitor defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2018-11-07
- Product Name: Monitor defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: The lithium-ion batteries involved may contain defective components.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems, in conjunction with its agent Philips (China) Investment Co., Ltd., initiated a voluntary Class II recall for specific monitored defibrillators (Registration Certificate No. 20163214004). This action was reported to the National Medical Products Administration (NMPA) on October 29, 2018, and publicly announced on November 7, 2018. The recall addresses a critical safety concern stemming from potentially defective components in the lithium-ion batteries of the M3538A model defibrillators. These faulty components could prevent the battery from charging or powering the device, potentially hindering its operation, particularly if a secondary battery or external power source is not available. Additionally, the battery's LED status indicator might fail, making it difficult to detect the malfunction. While the recall is global, the document explicitly states that the affected batches were not sold in China. Consequently, specific corrective actions and handling methods for the Chinese market were deemed 'Not Applicable,' as no units requiring intervention were distributed within the country.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/