# China NMPA Product Recall - Multifunctional incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/13f5b69b-b3fe-4710-80ce-b2f85d8a3dcf/
Source feed: China

> China NMPA product recall for Multifunctional incubator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling its multi-functional incubator.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Multifunctional incubator
- Recall Level: Level 2 Recall
- Recall Reason: If the product in question is used in a system with an original sealing design, a safety issue may occur if the top cover seal is properly cleaned.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its multifunctional incubators, as announced by the National Medical Products Administration (NMPA) on December 5, 2018. The company identified a potential safety hazard associated with the product: if the top cover is not properly cleaned, particularly when using a system with the original sealed design, it could compromise user safety. This recall falls under the regulatory purview of the NMPA, which oversees medical device safety and recalls in China. As a required action, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily removing the affected incubators from the market to address the identified cleaning-related safety concern. Detailed information regarding specific product models, specifications, and batch numbers is provided in the associated "Medical Device Recall Event Report Form" attachments, indicating the scope of the recall.

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