# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/ab012c80-0008-40e9-81a3-f7a9e272b252/
Source feed: China

> China NMPA product recall for Patient monitor by GE Healthcare (China) Co., Ltd. published October 22, 2018. Recall level: Level 3 Recall. GE Healthcare (China) Co., Ltd. initiated a voluntary Level III recall of its patient monitors, as r

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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: 2018-10-22
- 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. initiated a voluntary Level III recall of its patient monitors, as reported on October 22, 2018. The primary issue prompting this action was the potential for automatic restarts in the patient monitors, specifically triggered by prolonged network connections. This malfunction could disrupt continuous patient monitoring, presenting a safety risk in clinical environments. The recall pertains to patient monitors identified by various registration numbers, indicating a range of affected models. The National Medical Products Administration (NMPA) serves as the regulatory body overseeing this recall, hosting the official public notice. The required action by GE Healthcare is the recall of these manufactured patient monitors. For comprehensive details concerning the specific models, specifications, and batches impacted by this recall, stakeholders are directed to the 'Medical Device Recall Event Report Form'. This measure highlights the company's commitment to product safety and compliance with NMPA's regulatory standards to address and mitigate potential risks to patients.

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