# China NMPA Product Recall - Hemodynamic Modularized Multi-parameter Monitoring Platform

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/352bc264-21c6-40a3-a339-1fd75f6c7602/
Source feed: China

> China NMPA product recall for Hemodynamic Modularized Multi-parameter Monitoring Platform by Edwards Lifesciences LLC published March 18, 2022. Recall level: Level 2 Recall. On March 18, 2022, Edwards Lifesciences LLC, a medical technology company, initiated a voluntary Cla

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC is proactively recalling its Hemodynamic Modularized Multi-parameter Monitoring Platform patient monitor.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2022-03-18
- Product Name: Hemodynamic Modularized Multi-parameter Monitoring Platform
- Recall Level: Level 2 Recall
- Recall Reason: There is a problem with low tissue oxygen saturation (St02) values.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: On March 18, 2022, Edwards Lifesciences LLC, a medical technology company, initiated a voluntary Class II recall for its Hemodynamic Modularized Multi-parameter Monitoring Platform. This critical action was taken in response to identified issues where certain models and batches of the device displayed inaccurately low tissue oxygen saturation (StO2) values. Such inaccuracies could have significant implications in clinical settings, potentially leading to misinterpretations of patient physiological status and affecting timely and appropriate medical interventions. The recall is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA) and signifies a commitment to patient safety and product reliability. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Edwards Lifesciences LLC's proactive measure aims to mitigate these potential risks by removing the affected devices from circulation. Comprehensive details regarding the specific affected product models, specifications, and the full scope of required actions are outlined in the accompanying "Medical Device Recall Event Report Form," which serves as the primary reference for healthcare providers and users. This recall highlights the stringent quality controls and responsive actions necessary within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/