# China NMPA Product Recall - Central monitoring workstation セントララモニタ

Source: https://www.globalkeysolutions.net/records/china_product_recall/nippon-koden-kogyo-co-ltd/b34b94de-b4bb-4293-8383-667e9ddb5d6c/
Source feed: China

> China NMPA product recall for Central monitoring workstation セントララモニタ by Nippon Koden Kogyo Co., Ltd. published September 18, 2021. Recall level: Level 3 Recall. Nippon Kogaku Kogyo Co., Ltd. initiated a voluntary Class 3 recall of its Central Monitoring Worksta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nippon Koden Kogyo Co., Ltd. has initiated a voluntary recall of its Central Monitoring Station.
- Company Name: Nippon Koden Kogyo Co., Ltd.
- Publication Date: 2021-09-18
- Product Name: Central monitoring workstation セントララモニタ
- Recall Level: Level 3 Recall
- Recall Reason: After the product software was upgraded to 05-19, the machine made a sound and automatically restarted when clicking on the trend list in the inpatient review window.
- Discovering Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Manufacturing Company: Nippon Koden Kogyo Co., Ltd.
- Summary: Nippon Kogaku Kogyo Co., Ltd. initiated a voluntary Class 3 recall of its Central Monitoring Workstation (Central Monolithic Station) on September 18, 2021. This action was reported to the National Medical Products Administration (NMPA) by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. The recall stems from a critical software defect in specific product models and batches. Following a software upgrade to version 05-19, users have reported that clicking on the trend list within the inpatient review window causes the device to emit a sound and automatically restart. The manufacturer is undertaking this voluntary recall to address the performance issue. Detailed information regarding the specific product models, specifications, and batches affected by this recall is available in the accompanying "Medical Device Recall Event Report Form" attachment.

Company: https://www.globalkeysolutions.net/companies/nippon-koden-kogyo-co-ltd/cecd8b2c-0502-4cce-b225-e24ff7ea493c/