China NMPA Product Recall - Ultrasonic dental scaler (U600)

Guilin Woodpecker Medical Device Co., Ltd. initiated a voluntary Class III recall of its U600 ultrasonic dental scaler, as reported to the National Medical Products Administration (NMPA) on October 29, 2018, following the company's internal report dated October 12, 2018. The primary issue identified was the absence of functional grounding terminal markings on the device. This specific non-compliance violates sections 6.1y and 181 of the GB9706.1-2007 standard. The affected batch, produced around August 2017 (Production Number: 2017081277), involved 50 U600 units, with 28 units sold within China. The company assessed the defect's injury probability as extremely low, noting no related complaints or adverse events to date. Under NMPA's regulatory framework, Guilin Woodpecker Medical Device Co., Ltd. is issuing formal recall notices to distributors and users of the affected products. The required action involves coordinating with these parties to facilitate the return of all sold, non-compliant machines to the company for resolution, alongside proactive implementation of corrective and improvement measures.