# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-llc/757dca1d-cab1-404d-8f6f-b95859439ad2/
Source feed: China

> China NMPA product recall for Patient monitor by Edwards LLC published October 29, 2019. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on October 29, 2019, the voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC voluntarily recalls patient monitors
- Company Name: Edwards LLC
- Publication Date: 2019-10-29
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: The issue stems from a component manufacturing process failure in the product, resulting in intermittent readings and an error message displayed on the product's main unit.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards LLC
- Summary: The National Medical Products Administration (NMPA) announced on October 29, 2019, the voluntary Class II recall of patient monitors by Edwards Lifesciences LLC. This action was initiated by Edwards (Shanghai) Medical Supplies Co., Ltd. following the discovery of a critical manufacturing defect. The primary issue stems from a component manufacturing failure within the patient monitors, which resulted in the devices exhibiting intermittent readings and displaying various error messages on their main units. Such malfunctions pose a potential risk to patient care by providing unreliable data, which could impact clinical decision-making. Edwards Lifesciences LLC, the manufacturer, proactively initiated this recall to address the identified quality control issue. The regulatory framework overseeing this recall is the NMPA, which categorized it as a Class II recall, indicating that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The required action involves the comprehensive withdrawal of affected patient monitors from the market. Further detailed information regarding the specific models, specifications, and batch numbers of the products subject to this recall is provided in the "Medical Device Recall Event Report Form" attachment, ensuring all relevant parties are informed to facilitate the safe and effective removal of the faulty devices.

Company: https://www.globalkeysolutions.net/companies/edwards-llc/336376c3-7248-48f8-8be4-ef3a96e13219/