# China NMPA Product Recall - Exercise testing system; exercise testing system; cardiac function testing instrument; cardiac testing system; electrocardiogram (ECG) tester

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/58b2e5d9-325c-42e1-b12c-6e1c3d853725/
Source feed: China

> China NMPA product recall for Exercise testing system; exercise testing system; cardiac function testing instrument; cardiac testing system; electrocardiogram (ECG) tester by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published June 22, 2021. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has initiated a voluntary Level II re

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling motion testing systems, cardiac function testing devices, cardiac testing systems, and electrocardiogram (ECG) devices.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2021-06-22
- Product Name: Exercise testing system; exercise testing system; cardiac function testing instrument; cardiac testing system; electrocardiogram (ECG) tester
- Recall Level: Level 2 Recall
- Recall Reason: When using the CASE or CardioSoft system, if each of the following steps occurs in sequence: 1) The system is configured to enable "Auto Export" and the PDF and XML options are selected; 2) Patient A's test has been completed; 3) The user has not restarted the system; 4) The user goes to the database, manually selects a different patient (Patient B), and exports an XML file for Patient B; 5) The medical record viewing system (or similar system) running on the computer uses the PDF file path in the XML file exported for Patient B to import the PDF test report; then when viewing the medical records in the medical record viewing system (or similar system), the PDF test report belonging to Patient A will appear in Patient B's record.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has initiated a voluntary Level II recall for several of its exercise testing and cardiac function systems, including CASE and CardioSoft. This action, reported to the National Medical Products Administration (NMPA) and published by the Shanghai Municipal Drug Administration on June 22, 2021, addresses a critical software defect. The issue arises under specific conditions when the system is configured for "Automatic Export" of PDF and XML files. If a user completes Patient A's test, then, without restarting the system, manually selects Patient B in the database and exports Patient B's XML file, a data integrity error can occur. Subsequently, if a medical record viewing system imports Patient B's test report using the PDF file path from Patient B's XML, it incorrectly displays Patient A's PDF test report within Patient B's medical record. Affected products include various motion testing systems, cardiac function testers, cardiac testing systems, and electrocardiogram testing instruments, identified by specific registration certificate numbers. This recall aims to prevent patient data misidentification, ensuring the accuracy and integrity of patient medical records. The company has provided detailed information on affected models and batches in an accompanying recall event report.

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