China NMPA Product Recall - Programmable controller

Boston Scientific International Medical Trading (Shanghai) Co., Ltd., under the regulatory oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class II recall for its Programmer (Model 3200) on August 8, 2017. The recall stemmed from an identified issue where radio frequency interference could potentially alter wireless communications emitted from the programmable controller. In extremely rare instances, this interference might lead to an associated Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) executing unexpected commands. Thirteen global complaints related to this issue prompted the company's action. Within China, 18 units of the Programmer Model 3200 were affected, though these devices were not sold commercially and were exclusively used by Boston Scientific technicians. To address the problem, Boston Scientific developed and released an upgraded software solution. The company's required action involves arranging software upgrade services for all affected programmable controllers in the market as soon as the upgraded software is approved. This recall is managed through software updates and does not necessitate the return of any physical products.