# China NMPA Product Recall - Oxylog 3000, Oxylog 3000 Plus

Source: https://www.globalkeysolutions.net/records/china_product_recall/draegerwerk-ag-co-kgaa/1dc0687b-1401-4488-854b-ce18456f4e8e/
Source feed: China

> China NMPA product recall for Oxylog 3000, Oxylog 3000 Plus by Draegerwerk AG & Co. KGaA published February 21, 2017. Recall level: Level I. Dräger Medical Devices (Shanghai) Co., Ltd., representing manufacturer Drägerwerk AG & Co. KGaA, ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Draegerwerk AG & Co. KGaA
- Publication Date: 2017-02-21
- Product Name: Oxylog 3000, Oxylog 3000 Plus
- Recall Level: Level I
- Recall Reason: Dräger has discovered that its Oxylog 3000 and Oxylog 3000 Plus systems may generate a "potentiometer not connected/disconnected" error message. In such incidents, an audible and visual alarm is triggered, the respiratory system releases pressure, and the ventilation mode stops supplying air to the patient. No injuries have been reported in any of these cases.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draegerwerk AG & Co. KGaA
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd., representing manufacturer Drägerwerk AG & Co. KGaA, initiated a voluntary Class I recall for its Oxylog 3000 and Oxylog 3000 Plus emergency and transport ventilators. This action was reported to the National Medical Products Administration (NMPA) on February 21, 2017, following the company's internal discovery of a critical product malfunction. The main issue identified is that affected ventilators may display a "potentiometer not connected/disconnected" error. This error triggers alarms, releases system pressure, and halts ventilation, presenting a serious health risk to patients dependent on the device. No injuries were reported at the time of the recall. In adherence to NMPA's medical device recall regulations, Dräger's required actions involved issuing safety notices to customers, deploying maintenance teams to upgrade the ventilator system software, and distributing an additional instruction manual page to ensure safe operation. Globally, 404 units were affected, with 152 Oxylog 3000 and 252 Oxylog 3000 Plus units sold in China.

Company: https://www.globalkeysolutions.net/companies/draegerwerk-ag-co-kgaa/14744193-3c0e-42ad-b561-ad95278db9af/