# China NMPA Product Recall - emergency ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/allergan-shanghai-medical-devices-trading-co-ltd/71e48e55-bac6-4574-97ec-48cc0c0ce42e/
Source feed: China

> China NMPA product recall for emergency ventilator by Allergan (Shanghai) Medical Devices Trading Co., Ltd. published April 19, 2021. Recall level: Level 3 Recall. Viman (Shanghai) Medical Device Trading Co., Ltd. initiated a voluntary Class III recall of its emer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Viman (Shanghai) Medical Equipment Trading Co., Ltd. is voluntarily recalling emergency ventilators.
- Company Name: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Publication Date: 2021-04-19
- Product Name: emergency ventilator
- Recall Level: Level 3 Recall
- Recall Reason: In extremely rare cases, there is a very small probability that the device may experience a black screen and stop breathing while operating, accompanied by an audible and LED light alarm. This means that if the above-mentioned abnormality occurs, the device will no longer be usable.
- Discovering Company: Viman (Shanghai) Medical Device Trading Co., Ltd.
- Manufacturing Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Summary: Viman (Shanghai) Medical Device Trading Co., Ltd. initiated a voluntary Class III recall of its emergency ventilators (Registration Certificate No.: 国械注进20153080367), as reported on April 19, 2021, under the National Medical Products Administration (NMPA). This action followed a routine internal quality check at Viman's headquarters, which uncovered a potential issue: in extremely rare instances, the device might experience a black screen and cease ventilation during operation, triggering audible and LED light alarms and rendering it unusable. This preventative measure was taken despite Viman having received no user feedback or adverse event reports globally regarding this specific problem at the time of the recall notice. Operating within the NMPA's regulatory framework, the company proactively addressed the identified product defect. Viman's required actions involve recalling affected emergency ventilator models, specifications, and batches, with comprehensive details provided in the "Medical Device Recall Event Report Form" attachment. This recall highlights the critical role of continuous internal quality assurance in ensuring product reliability and patient safety within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/allergan-shanghai-medical-devices-trading-co-ltd/44f9ba9f-1a9b-46ba-8d34-bd77b4348e8d/