# China NMPA Product Recall - Patient monitor, clinical monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-shanghai-medical-supplies-co-ltd/b0dd4bd8-3505-41d6-bcef-73a38c83858a/
Source feed: China

> China NMPA product recall for Patient monitor, clinical monitor by Edwards (Shanghai) Medical Supplies Co., Ltd. published March 15, 2019. Recall level: Level 2 Recall. Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a voluntary Level II recall of its patient a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards (Shanghai) Medical Supplies Co., Ltd. has initiated a voluntary recall of patient monitors and clinical monitors.
- Company Name: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Publication Date: 2019-03-15
- Product Name: Patient monitor, clinical monitor
- Recall Level: Level 2 Recall
- Recall Reason: Incorrect installation of the product's AC power cord could cause liquid to enter the power supply, leading to an electrical short circuit and potentially causing a fire.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Summary: Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a voluntary Level II recall of its patient and clinical monitors on March 15, 2019, as announced by the National Medical Products Administration (NMPA). The recall stems from a critical safety concern related to the incorrect installation direction of the products' AC power cords. This installation defect poses a significant risk: liquid may enter the power supply unit, potentially leading to an electrical short circuit. Such a malfunction could result in fire, presenting a serious hazard to users and patients. The company proactively reported this issue and is implementing the recall to mitigate potential risks. This action falls under the regulatory oversight of the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. Edwards (Shanghai) Medical Supplies Co., Ltd. is required to identify and retrieve all affected units from the market. Specific details regarding the models, specifications, and batch numbers of the recalled devices are provided in a "Medical Device Recall Event Report Form," which accompanies the official announcement. This voluntary recall demonstrates the company's commitment to product safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/edwards-shanghai-medical-supplies-co-ltd/6cb13327-9284-43be-afa3-e467e6c339e2/