# China NMPA Product Recall - Oxylog 3000 plus ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/general-medical-equipment-shanghai-co-ltd/704d4422-1dfc-45e2-9e0c-e5c7552ad68a
Source feed: China

> China NMPA product recall for Oxylog 3000 plus ventilator by General Medical Equipment (Shanghai) Co., Ltd. published December 24, 2020. Recall level: Level 3. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its Oxylog 30

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators.
- Company Name: General Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2020-12-24
- Product Name: Oxylog 3000 plus ventilator
- Recall Level: Level 3
- Recall Reason: The registration certificate number on the label of the Oxylog 3000 plus ventilator has been updated according to the approved registration certificate, but the registration certificate number on the back cover of the corresponding instruction manual (version 5705324-15) has not been updated at the same time, resulting in a discrepancy between the registration certificate number information in the instruction manual and the label.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: General Medical Equipment (Shanghai) Co., Ltd.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall for its Oxylog 3000 plus ventilators, a measure announced by the National Medical Products Administration (NMPA) on December 24, 2020. The recall was prompted by an inconsistency in regulatory information: while the registration certificate number on the ventilator's physical label was correctly updated following an approval, the corresponding instruction manual (version 5705324-15) did not reflect this change simultaneously. This discrepancy resulted in differing registration certificate numbers between the product's label and its user documentation, potentially causing confusion regarding the device's official status. Under the regulatory guidance of the NMPA, Dräger Medical Devices (Shanghai) Co., Ltd. proactively reported this issue and is undertaking corrective action. The company is recalling all affected ventilators, specifically those under Registration Certificate No.: 国械注进20153084157, to ensure full compliance with national medical device regulations and rectify the documentation error. Further details concerning the specific product models, specifications, and batches involved in this recall are available in the "Medical Device Recall Event Report Form," which accompanied the NMPA's public notification. This event underscores the critical importance of maintaining meticulous accuracy and consistency across all product information components, including both external labeling and internal user manuals, to uphold regulatory standards and ensure clarity for users.

Company: https://www.globalkeysolutions.net/companies/general-medical-equipment-shanghai-co-ltd/e78bec1e-b5e6-44db-9c62-8b77dec44ed4