# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/5bc96446-5ed9-4e8e-b6ba-a3bfdb3413cc/
Source feed: China

> China NMPA product recall for Patient monitor by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published October 18, 2018. Recall level: Level 3 Recall. On October 18, 2018, the National Medical Products Administration (NMPA) and the Shanghai Food and D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalls patient monitors.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2018-10-18
- Product Name: Patient monitor
- Recall Level: Level 3 Recall
- Recall Reason: When multiple patient monitors are connected to the same network and the network is overloaded for an extended period, the monitors may automatically restart. During network outages, the patient monitors will not automatically restart.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On October 18, 2018, the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration announced a voluntary Class III recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The recall pertains to specific patient monitors, identified by registration certificates such as CFDA (Imported) 2014 No. 3212942 and CFDA (No. 3212981), issued under the former China Food and Drug Administration. The primary issue identified is a software-related malfunction: when multiple patient monitors are connected to the same network and that network experiences prolonged overloading, the devices may automatically restart. Critically, these monitors will not terminate the restart process even when network problems persist. This defect presents a concern for continuous and reliable patient monitoring, potentially impacting patient care by causing intermittent service disruptions. In response to this identified risk, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has proactively undertaken a voluntary recall to address the problem. This action demonstrates the company's commitment to product safety and compliance with the regulatory framework governing medical devices in China. Further comprehensive details regarding the specific models, product specifications, and affected manufacturing batches are formally documented in the "Medical Device Recall Event Report Form" available through the NMPA.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/