# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/draeger-medical-systems-inc/3f64548d-db0e-41b5-bf43-f6ca6d8104c6/
Source feed: China

> China NMPA product recall for Patient monitor by Draeger Medical Systems, Inc. published July 27, 2017. Recall level: Level 2. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level II recall of specific patien

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Devices (Shanghai) Co., Ltd. voluntarily recalls patient monitors
- Company Name: Draeger Medical Systems, Inc.
- Publication Date: 2017-07-27
- Product Name: Patient monitor
- Recall Level: Level 2
- Recall Reason: This patient monitor uses a Kontron operating unit (Cockpit), which contains 4GB memory modules supplied by Virtium and Swissbit respectively. The memory module supplied by Virtium may cause malfunctions in the monitor.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Draeger Medical Systems, Inc.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level II recall of specific patient monitors, as reported to the National Medical Products Administration (NMPA) on June 5, 2017, with public notification on July 27, 2017. The recall was prompted by a potential malfunction stemming from the memory module within the affected devices.The patient monitors, registered under code 20163210771, are critical for displaying multi-parameter physiological signals for adult, pediatric, and neonatal patients, utilizing the Infinity M540 monitor host and Infinity C500/C700 displays. The root cause was traced to the Kontron operating unit (Cockpit), which contains 4GB memory modules from both Virtium and Swissbit. Investigations confirmed that memory modules supplied by Virtium were responsible for the potential monitor malfunctions.This global recall specifically impacted seven units in China, encompassing C500 and C700 models identified by various batch numbers. To address the defect, Dräger Medical Devices (Shanghai) Co., Ltd. committed to replacing all Virtium-supplied memory modules with modules from Swissbit. This corrective action ensures the continued safety and reliable performance of the patient monitors in compliance with NMPA's medical device recall regulations.

Company: https://www.globalkeysolutions.net/companies/draeger-medical-systems-inc/01c9dee0-9052-4448-b223-b38afbd23e44/