# China NMPA Product Recall - Central monitoring system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-optoelectronic-medical-electronic-instruments-co-ltd/d1b8a934-2d50-4c8a-a69f-1a2bbfbd7404/
Source feed: China

> China NMPA product recall for Central monitoring system by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. published January 22, 2021. Recall level: Level 2 Recall. On January 22, 2021, the National Medical Products Administration (NMPA) announced that Shanghai Opt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. has initiated a voluntary recall of its central monitoring system.
- Company Name: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Publication Date: 2021-01-22
- Product Name: Central monitoring system
- Recall Level: Level 2 Recall
- Recall Reason: Software malfunctions of the ORG-9100(K) multi-channel telemetry signal receiver: When used with the central monitoring system (CNS-9101), after January 1, 2021, the central monitoring system does not display arrhythmia review data or ST segment review data; instead, data from 1970 is saved. Additionally, NIBP review data is not displayed; only data displayed on the overall bedside or individual screens can be referenced. NIBP measurements are displayed correctly, but the numerical values are dimmed.
- Discovering Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Manufacturing Company: Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd.
- Summary: On January 22, 2021, the National Medical Products Administration (NMPA) announced that Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Class II recall of its central monitoring system (CNS-9101), including the multi-channel telemetry signal receiver ORG-9100(K). The recall stems from a significant software malfunction identified after January 1, 2021. The primary issues include the central monitoring system failing to display arrhythmia and ST segment review data, instead saving erroneous data from the year 1970. Furthermore, NIBP review data is not displayed, requiring users to rely solely on overall bedside or individual screen displays. While NIBP measurements are accurate, their values appear dimmed, potentially leading to user confusion or misinterpretation. This voluntary recall is a direct response to these critical software defects impacting patient data display and review capabilities. Affected product models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/shanghai-optoelectronic-medical-electronic-instruments-co-ltd/0ee5a2e4-da50-48dc-874b-88344523fa76/