China NMPA Product Recall - Stereoscopic radiofrequency ablation platform

Acrylic Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its Stereoscopic Radiofrequency Ablation Platform, as publicly announced on January 13, 2017, under the guidance and oversight of the National Medical Products Administration (NMPA). This significant action addresses a critical safety deficiency identified within certain units of the medical device. The primary issue involves the absence of a protective casing for the high-voltage ion pump power supply. This design oversight presents a substantial electric shock hazard to maintenance engineers, who could be exposed to the modulator's high-voltage ion pump power supply during routine on-site servicing and maintenance activities. The company's decision to conduct a voluntary recall underscores its commitment to ensuring product safety and mitigating potential risks to personnel involved in the upkeep of their medical equipment. A Level II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The regulatory framework requires manufacturers to address such deficiencies promptly. Acrylic Medical Devices is taking the necessary steps to rectify this product defect, with comprehensive information on the specific models, specifications, and batches of affected devices detailed in the accompanying 'Medical Device Recall Event Report Form.' This action is crucial for maintaining the safety standards expected for medical devices marketed in China.