# China NMPA Product Recall - Defibrillator; Defibrillator/Monitor; Monitor/Defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/cbfc6bc0-3181-409e-8cb9-b21de565fa1b/
Source feed: China

> China NMPA product recall for Defibrillator; Defibrillator/Monitor; Monitor/Defibrillator by Philips (China) Investment Co., Ltd. published May 18, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its defibrillators, d

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling defibrillators, defibrillators/monitors, and monitor/defibrillators.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-05-18
- Product Name: Defibrillator; Defibrillator/Monitor; Monitor/Defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: The in vivo electrode pads sold between April 1, 2010 and May 20, 2019 may deteriorate over time and may not be safe to use unless periodic checks are performed as instructed in the Instruction of Use (IFU). Customers can use the electrode pads normally if they pass the checks according to the IFU. The IFU does not determine when to stop using deteriorated electrode pads by setting a maximum number of sterilization cycles, but rather by a series of checks. Damaged in vivo electrode pads may not be able to deliver electric shocks. In addition, damaged electrode pads may cause cross-contamination of bodily fluids between patients and between patients and users.
- 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 for its defibrillators, defibrillator/monitors, and monitor/defibrillators on May 18, 2020. This action, overseen by the National Medical Products Administration (NMPA), addresses critical safety concerns related to in-body electrode plates manufactured and sold between April 1, 2010, and May 20, 2019.The primary issue stems from the potential for these electrode plates to wear out over time, posing significant risks. Worn plates may fail to deliver necessary electrical shocks, a critical function for life-saving devices. Furthermore, damaged plates present a serious risk of cross-contamination from bodily fluids, potentially affecting patients and users. While the instructions for use (IFU) outline periodic operational checks and inspections to determine usability, the recall highlights that these checks are crucial for ensuring safety, and implies a potential gap or need for enhanced vigilance given the severe consequences of failure.Under the NMPA's regulatory guidance, Philips is recalling affected products, with detailed specifications available in a "Medical Device Recall Event Report Form." Users are advised to continue using electrode plates only if they pass thorough inspection according to the IFU. This recall emphasizes the company's commitment to patient safety and adherence to medical device regulations.

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