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

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.