# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/a3e7b16c-fbde-477e-92eb-201bc1a1edfd/
Source feed: China

> China NMPA product recall for Patient monitor by GE Healthcare (China) Co., Ltd. published March 11, 2019. Recall level: Level 3 Recall. GE Healthcare (China) Co., Ltd. publicly announced a voluntary Level III recall of several models of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare (China) Co., Ltd. voluntarily recalls patient monitors
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2019-03-11
- Product Name: Patient monitor
- Recall Level: Level 3 Recall
- Recall Reason: Prolonged network connection may cause the device to restart automatically.
- Discovering Company: GE Healthcare (China) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare (China) Co., Ltd. publicly announced a voluntary Level III recall of several models of its patient monitors, as documented on March 11, 2019. This significant action was prompted by the discovery of a critical technical flaw: the patient monitors possess the potential for unexpected automatic restarts, particularly when maintained under prolonged network connection. This issue raises concerns regarding device reliability and continuous patient monitoring. The affected medical devices are identified by their regulatory approval numbers, including Su Shi Yao Jian Xie (Zhun) Zi 2011 No. 2210950, Guo Xie Zhu Zhun 20163211579, and Su Xie Zhu Zhun 20152211080, indicating their previous registration with Chinese authorities. The recall is being conducted under the oversight and regulatory framework of the National Medical Products Administration (NMPA) of China. While specific inspection dates are not provided in this announcement, the recall itself serves as a corrective action in response to identified product deficiencies. The required action is a voluntary recall initiated by the company to address the identified safety risk. Additional comprehensive details concerning the precise models, specifications, and involved production batches of the patient monitors are accessible within the official 'Medical Device Recall Event Report Form'. This proactive recall aims to mitigate potential risks to patients and ensure the integrity of medical device performance in clinical settings.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/