# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-finland-oy/a0e76619-b1e7-45f1-b978-0e9d721a7529/
Source feed: China

> China NMPA product recall for Patient monitor by GE Healthcare Finland Oy published September 27, 2017. Recall level: Not applicable (recalled products not sold in China). GE Healthcare Finland Oy initiated a voluntary recall for specific patient monitors due to a critica

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Finland Oy initiates voluntary recall of patient monitors
- Company Name: GE Healthcare Finland Oy
- Publication Date: 2017-09-27
- Product Name: Patient monitor
- Recall Level: Not applicable (recalled products not sold in China)
- Recall Reason: When the Patient Data Module (PDM, software version V2.6) is used with a patient monitor with host software version V2.0.7 or earlier, the impedance respiratory monitoring of the PDM module in software version V2.6 will not generate visual or audible apnea alarms in the event of an apnea event.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Finland Oy
- Summary: GE Healthcare Finland Oy initiated a voluntary recall for specific patient monitors due to a critical software malfunction, as reported to the National Medical Products Administration (NMPA) on September 27, 2017, with an internal company report dated August 8, 2017. The issue involves Patient Data Modules (PDM, software version V2.6) when used with host software version V2.0.7 or earlier on patient monitor models B850, B650, and B450. Under these conditions, the monitors fail to produce essential visual and auditory apnea alarms during an apnea event. Instead, the device incorrectly displays the respiratory rate, potentially delaying critical medical response. While no patient injuries have been reported, this defect poses a significant patient safety risk. The recall, overseen by the NMPA in China through its reporting agent GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., primarily affects products sold in regions such as the European Economic Area and the United States, as the specific recalled products were not distributed within China. The required action is the recall of these affected patient data modules to mitigate potential harm and uphold device reliability.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-finland-oy/858eadf0-65d6-4d5f-89c3-37aa5f5b8fa1/