# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/allergan-shanghai-medical-devices-trading-co-ltd/1b09fbd8-17fe-4ccf-b3a3-6c098175a405
Source feed: China

> China NMPA product recall for Ventilator by Allergan (Shanghai) Medical Devices Trading Co., Ltd. published March 15, 2021. Recall level: Level 2 Recall. Viman (Shanghai) Medical Device Trading Co., Ltd. has initiated a voluntary Class II recall of its V

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Viman (Shanghai) Medical Devices Trading Co., Ltd. is voluntarily recalling Ventilator ventilators.
- Company Name: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Publication Date: 2021-03-15
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The pneumatic valve sensor provided by the supplier may not fully meet the requirements, and there is a very small probability that it may cause abnormal equipment startup (displaying a device malfunction on the screen) or the equipment to stop supplying air (along with an alarm). This means that if the above abnormalities occur, the equipment will not function properly.
- 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. has initiated a voluntary Class II recall of its Ventilator ventilators (Registration Certificate No.: 20153081989). This preventative action stems from internal quality checks conducted at Viman's headquarters in 2020, which revealed that a pneumatic valve sensor from a supplier did not consistently meet quality specifications. The identified issue could, with a very low probability, cause abnormal device startup, displaying a "Device Fault" message, or lead to device malfunction accompanied by an alarm, rendering the ventilator non-functional. As of the recall notice date (March 15, 2021), Viman has not received any user feedback or adverse event reports globally related to this specific sensor issue. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA). Affected product models, specifications, and batch numbers are detailed in the "Medical Device Recall Event Report Form," which is available for download. This recall ensures patient safety by addressing a potential component defect before it leads to actual harm.

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