China NMPA Product Recall - Ultrasonic dental scaler (D600)

Guilin Woodpecker Medical Device Co., Ltd. initiated a voluntary Class III recall of its Ultrasonic Dental Scaler (Model D600) following a report submitted on October 12, 2018, and published by the National Medical Products Administration (NMPA) on October 29, 2018. The recall stems from a labelling non-compliance where the product lacked functional grounding terminal markings. This issue violates specific requirements outlined in GB9706.1-2007, sections 6.1 (y) and 181.

Although the company noted an extremely low probability of injury and very small risk, with no reported complaints or adverse events linked to this specific defect, the recall was proactively undertaken to ensure adherence to regulatory standards. The affected batch, identified by production number 2018042101, involved 30 units produced, with two sold within China.

As part of the corrective action, Guilin Woodpecker Medical Device Co., Ltd. is issuing recall notices to all involved dealers and users. The required action involves retrieving the sold devices, which will then be stored and processed in collaboration with distributors and end-users. The company emphasizes its commitment to rectifying the non-compliance and implementing necessary improvements.