# China NMPA Product Recall - Multifunctional incubator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/77760e9e-ebea-47bf-84e8-8601036457a1/
Source feed: China

> China NMPA product recall for Multifunctional incubator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published August 08, 2019. Recall level: Level 2 Recall. On August 8, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a volunt

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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: 2019-08-08
- Product Name: Multifunctional incubator
- Recall Level: Level 2 Recall
- Recall Reason: In some batches of products, eight fasteners had torque values lower than specified during production. In the unlikely event that these fasteners would loosen to their release point, the canopy could detach and fall. Furthermore, there is a possibility that loosened fasteners could fall off, potentially causing injury to the patient.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On August 8, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for certain batches of its multifunctional incubators. This action, reported under the oversight of the National Medical Products Administration (NMPA), was prompted by a critical manufacturing defect. It was discovered that eight fasteners in the affected products had torque values below the specified requirements. This deficiency created a risk that the under-torqued fasteners could loosen, potentially leading to the separation and fall of the incubator's canopy. Furthermore, there was a possibility that loose fasteners could detach and fall, posing a risk of injury to patients. To address these safety concerns, the company proactively recalled the implicated incubators, as detailed in their "Medical Device Recall Event Report Form," which includes specific product models, specifications, and batch numbers. This recall highlights the importance of rigorous quality control in medical device production to safeguard patient well-being.

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