# China NMPA Product Recall - Central workstation monitoring system; central workstation; telemetry monitoring system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/bcf63581-b38c-4b7f-98e6-5f524a496171/
Source feed: China

> China NMPA product recall for Central workstation monitoring system; central workstation; telemetry monitoring system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 12, 2019. Recall level: Level 3 Recall. On December 12, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling its central workstation monitoring system (including central workstations, telemetry monitoring systems, and other related products).
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-12-12
- Product Name: Central workstation monitoring system; central workstation; telemetry monitoring system
- Recall Level: Level 3 Recall
- Recall Reason: Recently, potential network security vulnerabilities have been discovered in certain versions of central workstations and telemetry servers. Unauthorized personnel may use special techniques to gain network access privileges, potentially leading to targeted network attacks that render devices unusable or alter device settings and alarm limits, resulting in loss of monitoring or alarms.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On December 12, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall of several medical devices, including central workstation monitoring systems, telemetry monitoring systems, and central workstations. This action, reported to the National Medical Products Administration (NMPA) and publicized by the Shanghai Municipal Drug Administration, was prompted by the discovery of potential network security vulnerabilities within certain versions of these central workstations and telemetry servers. The identified flaw poses a risk where unauthorized individuals could exploit special techniques to gain network access permissions. This unauthorized access could potentially lead to targeted network attacks, rendering the equipment unusable, or altering critical equipment settings and alarm limits. Such modifications could result in the loss of patient monitoring capabilities or the failure of alarm systems, posing significant safety concerns. Detailed information regarding the specific affected product models, specifications, and batches is available in an accompanying "Medical Device Recall Event Report Form." This proactive measure by GE Healthcare underscores the company's commitment to patient safety and product integrity under the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/