China NMPA Product Recall - Diagnostic Ultrasound System and Transducers

Philips Ultrasound, Inc. has initiated a voluntary Class II recall for specific Diagnostic Ultrasound System and Transducers, a measure publicly announced by the National Medical Products Administration (NMPA) on August 25, 2021. This action, reported to the NMPA by Philips (China) Investment Co., Ltd., stems from a critical software defect affecting designated models, specifically the EPIQ and EPIQAFFINITI ultrasound systems, across certain manufacturing batches. The identified issue manifests as a system unresponsiveness or "lock-up" that occurs when clinicians attempt to review or adjust xPlane test results. This malfunction directly impairs the systems' functionality, preventing uninterrupted clinical use and potentially impacting diagnostic workflow. The voluntary recall serves as the company's required corrective action under the NMPA's regulatory oversight to address this technical anomaly. By recalling the affected products, Philips Ultrasound, Inc. aims to mitigate potential operational risks and uphold device reliability and patient safety standards. Comprehensive details regarding the affected product models, specifications, and batches are provided in the accompanying Medical Device Recall Event Report Form.