# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/f7216c53-4826-47b5-aabc-bbb67a834a15/
Source feed: China

> China NMPA product recall for Ventilator by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 11, 2018. Recall level: Level 3 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiates voluntary recall of ventilators
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2018-12-11
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: The product in question uses a 15mm conical female connector. The ventilator's inspiratory safety protection device may disconnect from the breathing circuit, resulting in insufficient oxygenation of the patient during ventilation and increasing the possibility of hypoxia.
- 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 III recall of its ventilators following a critical safety issue identified in the device. This recall was reported under the Shanghai Food and Drug Administration Medical Device Recall 2018-271 and overseen by the National Medical Products Administration (NMPA). The primary concern involves the ventilator's inspiratory safety protection device, specifically a 15mm conical female connector. This component has the potential to disconnect from the breathing circuit during operation. Such a disconnection could severely compromise patient safety by leading to insufficient oxygenation, thereby increasing the risk of hypoxia in patients undergoing ventilation. While specific inspection dates are not detailed in the provided document, the recall was publicly announced on December 11, 2018. As a result of this potential hazard, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalled affected ventilator models, specifications, and batches, as detailed in the 'Medical Device Recall Event Report Form.' This action is a crucial measure to mitigate patient risk associated with the identified device malfunction.

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