China NMPA Product Recall - Ultrasonic dental scaler (SHEL-P)

Guilin Yikeshi Medical Device Co., Ltd. voluntarily initiated a Class III recall for four units of its SHEL-P Ultrasonic Dental Scaler, as publicly reported by the National Medical Products Administration (NMPA) on November 5, 2019. The recall was prompted by internal testing, which revealed that the device's input power did not meet the specifications of the GB9706.1-2007 Medical Electrical Equipment standard. This non-compliance was identified through random product sampling.The affected products, bearing Registration No.: Guixiezhuzhun 20182230021, were manufactured and sold by Guilin Yikeshi Medical Device Co., Ltd. The regulatory action falls under the NMPA's framework, with the company submitting a recall event report on September 2, 2019.To address the issue, the company committed to retrieving all four sold ultrasonic scalers from the market. The required actions involve disassembling and scrapping the recalled units to ensure they are no longer in circulation. Furthermore, Guilin Yikeshi Medical Device Co., Ltd. is obligated to document and register any discrepancies in their inspection reports, ensuring full compliance with regulatory standards.