# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/koo-medical-equipment-shanghai-co-ltd/77e75d76-2fd6-4dba-98ed-b2ec0cfc6261/
Source feed: China

> China NMPA product recall for Patient monitor by Koo Medical Equipment (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 2 Recall. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its patient mon

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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: 2017-07-14
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: The product's memory module may cause the monitor to malfunction.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Koo Medical Equipment (Shanghai) Co., Ltd.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its patient monitors, as announced by the National Medical Products Administration (NMPA) on July 14, 2017. The recall was prompted by a critical issue where the memory module of the affected devices could malfunction, subsequently leading to a failure of the patient monitor. This potentially impacts the reliability and performance of the monitors, which are crucial for patient care. The specific registration number for the recalled product is 20163210771. The company reported this issue and voluntarily undertook the recall to address the potential risk posed by the malfunctioning components. Detailed information regarding the models, specifications, and batch numbers of the affected products is available in the "Medical Device Recall Event Report Form," an attachment to the NMPA's public notification. This action underscores the regulatory framework's role in ensuring the safety and efficacy of medical devices in the market, with companies responsible for identifying and rectifying product deficiencies. Dräger's proactive recall demonstrates compliance with NMPA's medical device recall regulations to safeguard patient health.

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