# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/nippon-kogaku-industries-ltd/c356002c-bbcc-4a5a-8e76-4a8fd54da8bf/
Source feed: China

> China NMPA product recall for Patient monitor by Nippon Kogaku Industries, Ltd. published August 21, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued an announcement on August 21, 2024, regar

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nippon Kogaku Industries, Ltd. has initiated a voluntary recall of its patient monitors.
- Company Name: Nippon Kogaku Industries, Ltd.
- Publication Date: 2024-08-21
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: Host software can cause display malfunctions.
- Discovering Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Manufacturing Company: Nippon Kogaku Industries, Ltd.
- Summary: The National Medical Products Administration (NMPA) issued an announcement on August 21, 2024, regarding a voluntary Class II recall initiated by Nippon Kohden Kogyo Co., Ltd. This recall was prompted by reports from Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd., concerning display malfunctions stemming from host software issues in certain patient monitoring devices. The affected products include the Patient Monitor Bedside Monota (registration number 20173070840) and the Patient Monitor Patient Monitoring Instrument (National Medical Device Registration Certificate 20163075156). Nippon Kohden Kogyo Co., Ltd. is undertaking this corrective action to address the identified performance deficiencies. It is important to note that the specific products involved in this recall were not imported into China. Further detailed information, including specific models, specifications, and batch numbers, is available in the accompanying Medical Device Recall Event Report Form. This action underscores the regulatory framework's commitment to patient safety and device reliability within the medical technology sector under NMPA oversight.

Company: https://www.globalkeysolutions.net/companies/nippon-kogaku-industries-ltd/7fc6bd4a-f7ad-46cc-a40d-9dd63ecf93e0/