# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/ced5ac11-f38a-469e-b94d-092b6e26f70f/
Source feed: China

> China NMPA product recall for Ventilator by Datex-Ohmeda, Inc. published June 20, 2022. Recall level: Level 1. Datex-Ohmeda, Inc., in cooperation with GE Healthcare Systems Trading Development (Shanghai) Co., Lt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datex-Ohmeda, Inc. has initiated a voluntary recall of its Ventilator ventilator.
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2022-06-20
- Product Name: Ventilator
- Recall Level: Level 1
- Recall Reason: There is a defect in the internal backup battery.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: Datex-Ohmeda, Inc., in cooperation with GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., initiated a voluntary Class I recall of its Ventilator machine, as announced by the National Medical Products Administration (NMPA) on June 20, 2022. The recall was prompted by a critical safety issue: a defective internal backup battery within the medical device. This malfunction poses a significant risk, leading to the highest classification of recall, Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The affected Ventilator machine carries Registration Certificate No.: 20173081051. The NMPA oversees this regulatory action, ensuring that medical devices comply with established safety and quality standards in China. As part of the required actions, Datex-Ohmeda, Inc. is recalling all affected units. Specific details concerning the product models, specifications, and batch numbers subject to this recall are available in the comprehensive "Medical Device Recall Event Report Form" accessible through the NMPA's official website. This proactive measure aims to mitigate potential patient harm by removing the faulty devices from circulation and upholding medical device safety protocols.

Company: https://www.globalkeysolutions.net/companies/datex-ohmeda-inc/3f7d50b4-53f8-4a07-a7a6-7a3c0147c9e2/