# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-shanghai-medical-supplies-co-ltd/6ea11045-fb8a-4e3c-ad47-0bd2b0043e6b/
Source feed: China

> China NMPA product recall for Patient monitor by Edwards (Shanghai) Medical Supplies Co., Ltd. published April 09, 2020. Recall level: Level 3 Recall. On April 9, 2020, Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a Class III voluntary reca

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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.
- Company Name: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Publication Date: 2020-04-09
- Product Name: Patient monitor
- Recall Level: Level 3 Recall
- Recall Reason: The patient monitor (model: EV1000A) is running software version 1.9.0.760, but the correct version should be 1.9.0.763.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Summary: On April 9, 2020, Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a Class III voluntary recall for specific EV1000A patient monitors manufactured between July and August 2019. The recall, reported through the Shanghai Municipal Drug Administration under the National Medical Products Administration (NMPA) framework, addresses a significant issue concerning incorrect software installation. Affected devices were found to have software version 1.9.0.760, while the correct and approved version should be 1.9.0.763. This discrepancy necessitated a market correction to ensure product compliance and patient safety. While the primary action involves essential software updates rather than a physical return of the product, the company has nevertheless launched a voluntary recall to systematically address all affected units. This proactive measure ensures that all deployed patient monitors are brought up to the required specifications, underscoring the company's commitment to regulatory adherence and product integrity.

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