China NMPA Product Recall - Digital color ultrasound diagnostic device

Hitachi Aloka Medical Corporation initiated a voluntary Class II recall for its "Digital Color Ultrasound Diagnostic Device" on January 28, 2016, reporting the action to China's National Medical Products Administration (NMPA). This measure was taken after the company identified a potential issue during a software upgrade evaluation, revealing that the C251 probe on some devices might reach excessive surface temperatures under extreme operating conditions. The recall affects specific units of the ARIETTA 60 and ARIETTA 70 models. Importantly, all eight identified ARIETTA 60 units destined for the Chinese market were contained within the importer, Hitachi Medical (Guangzhou) Co., Ltd.'s bonded warehouse and had not been distributed to medical facilities. The company assessed the health risk as extremely low, confirming no related adverse events had been reported. The required action involves a software upgrade performed by the manufacturer's after-sales technical department for all affected devices, ensuring adherence to safety standards before their release for clinical use.