# China NMPA Product Recall - Central Monitoring Station

Source: https://www.globalkeysolutions.net/records/china_product_recall/nippon-optoelectronics-industry-co-ltd/055b6156-1dd4-4824-bdbc-aa6a4d95065f/
Source feed: China

> China NMPA product recall for Central Monitoring Station by Nippon Optoelectronics Industry Co., Ltd. published June 01, 2015. Recall level: . On June 1, 2015, Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd., the responsible u

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. voluntarily recalls central monitoring workstations.
- Company Name: Nippon Optoelectronics Industry Co., Ltd.
- Publication Date: 2015-06-01
- Product Name: Central Monitoring Station
- Recall Reason: We received reports from component manufacturers about response delays when using this product. Our investigation revealed that there may be a delay of several seconds between the waveform and the alarm notification. If there is a delay between the waveform and the alarm notification, medical staff may not be able to immediately grasp changes in the patient's condition.
- Discovering Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Manufacturing Company: Nippon Optoelectronics Industry Co., Ltd.
- Summary: On June 1, 2015, Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd., the responsible unit in China for Nippon Koden Kogyo Co., Ltd., initiated a voluntary recall of its Central Monitoring Workstations, specifically model CNS-6201. This action was taken under the oversight of the National Medical Products Administration (NMPA). The recall stemmed from reports indicating a response delay, potentially several seconds long, in the device's waveform and alarm notifications. This delay could critically affect medical personnel's ability to immediately detect and respond to changes in a patient's vital signs and cardiac condition, particularly for adults, children, and newborns.
The primary issue identified was a component-related delay that could prevent healthcare workers from promptly grasping evolving patient conditions. While the bedside monitors continued to function and trigger alarms, the central workstation's delay posed a risk to timely intervention. Despite no reported health problems or patient harm linked to this specific issue, the company is implementing comprehensive corrective actions. These actions include direct notification to all known delivery locations and performing internal setting improvements to the components (specifically, Video BIOS settings) to rectify the delay, thereby enhancing product usability and patient safety in medical facilities. This proactive measure aims to ensure the accuracy and reliability of centralized patient monitoring.

Company: https://www.globalkeysolutions.net/companies/nippon-optoelectronics-industry-co-ltd/e0fb547d-3363-4f51-b1ee-a6cd50c11cd8/