China NMPA Product Recall - Stereoscopic radiofrequency ablation platform

Acrylic Medical Devices (Shanghai) Co., Ltd., the responsible unit in China for Accuray Incorporated, initiated a voluntary Class II recall of its Stereoscopic Radiofrequency Absorption Spectroscopy (SRS) Platform, specifically the CyberKnife™ C Series. This recall, reported on December 21, 2016, and published by the National Medical Products Administration (NMPA) on January 13, 2017, addressed a significant safety concern for maintenance personnel. The primary issue identified was the absence of a protective casing for the high-voltage ion pump power supply on some machines. This design flaw posed a potential electric shock hazard to service engineers performing on-site maintenance of the modulator system. While the defect did not endanger system users or patients, it presented a serious occupational safety risk. The recall affected 9 units, with 7 specifically identified by serial numbers, and impacted numerous countries including China, France, and the USA. In response, Acrylic Medical Devices (Shanghai) Co., Ltd. implemented required corrective actions, which involved sending written notifications to all users of the affected devices. Subsequently, the company conducted on-site inspections and installed the necessary protective housings to eliminate the electric shock hazard, thereby resolving the product defect.