# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/koo-medical-equipment-shanghai-co-ltd/f38f370b-5fdc-4efa-bf22-b31fb09994f6/
Source feed: China

> China NMPA product recall for Patient monitor by Koo Medical Equipment (Shanghai) Co., Ltd. published November 13, 2017. Recall level: Level 2 Recall. On November 13, 2017, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Devices (Shanghai) Co., Ltd. voluntarily recalls patient monitors
- Company Name: Koo Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: When the dual-module component of the product is used in a patient monitor, liquid seepage may cause inaccurate invasive blood pressure measurements.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Koo Medical Equipment (Shanghai) Co., Ltd.
- Summary: On November 13, 2017, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its patient monitors, specifically those registered under No.: 20163210771. This action was formally reported to the National Medical Products Administration (NMPA) as part of their regulatory oversight. The core issue identified was that the dual-module component of the affected patient monitors could experience liquid leakage when in use, directly leading to inaccurate invasive blood pressure measurements. Accurate blood pressure data is critical for precise patient diagnosis and treatment, and any compromise in its reliability could potentially lead to adverse health consequences or incorrect clinical decisions.
A Class II recall signifies that the product might cause temporary or reversible adverse health issues, or that the likelihood of serious adverse effects is remote. Dräger Medical Devices (Shanghai) is taking steps to mitigate these risks by removing the affected products from circulation. The company has provided comprehensive details, including specific models, specifications, and batch numbers of the recalled devices, within the "Medical Device Recall Event Report Form" and associated attachments to facilitate the identification and removal of all impacted units. This demonstrates the company's commitment to product quality and patient safety under the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/koo-medical-equipment-shanghai-co-ltd/629448d1-2f5c-4db0-8ac4-522b6d76800f/