# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/allergan-shanghai-medical-devices-trading-co-ltd/da431a24-919c-428f-9f87-02a9530c6926/
Source feed: China

> China NMPA product recall for Ventilator by Allergan (Shanghai) Medical Devices Trading Co., Ltd. published August 20, 2020. Recall level: Level 3 Recall. Viman (Shanghai) Medical Device Trading Co., Ltd. initiated a voluntary Class III recall of its Vent

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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: 2020-08-20
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: In extremely rare cases, if the device's battery connection module fails unexpectedly, the device may be unable to power on and operate normally when powered by battery, and the self-test program may not promptly alert the user to this fault, potentially delaying patient treatment.
- 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 Ventilator machines (Registration Certificate No.: 20153081989) on August 20, 2020. This action was prompted by the discovery of a potential issue with the device's battery connection module during routine product maintenance by Viman's after-sales technicians.
The main concern is that in extremely rare circumstances, such as liquid exposure or electrostatic discharge within the battery compartment, the ventilator may fail to power on normally when operating solely on battery power. While the device functions correctly when connected to an external AC or DC power supply, its internal self-test program may not promptly alert users to this underlying battery fault condition. The primary risk associated with this malfunction is the potential for delayed patient treatment if the device fails to start without an external power source and users have not prepared alternative emergency ventilation equipment.
As of the recall date, Viman (Shanghai) Medical Device Trading Co., Ltd. had not received any global or Chinese market reports from users regarding adverse events related to this specific issue. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Specific details regarding affected product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form," which accompanies the official notice. This proactive recall aims to mitigate any potential patient safety risks posed by the identified battery module issue.

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