# China NMPA Product Recall - Ultrasonic dental scaler (U600)

Source: https://www.globalkeysolutions.net/records/china_product_recall/guilin-woodpecker-medical-instrument-co-ltd/3ff1e360-708f-4dc0-81be-a41809f68f04/
Source feed: China

> China NMPA product recall for Ultrasonic dental scaler (U600) by Guilin Woodpecker Medical Instrument Co., Ltd. published October 29, 2018. Recall level: Level 3. Guilin Woodpecker Medical Device Co., Ltd. initiated a voluntary Class III recall of its U600 ultras

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guilin Woodpecker Medical Device Co., Ltd. is voluntarily recalling its U600 ultrasonic dental scaler.
- Company Name: Guilin Woodpecker Medical Instrument Co., Ltd.
- Publication Date: 2018-10-29
- Product Name: Ultrasonic dental scaler (U600)
- Recall Level: Level 3
- Recall Reason: The lack of a functional grounding terminal symbol does not comply with the requirements of GB9706.1-2007 6.1y), 181). The probability of this defect causing injury is extremely low, and the risk is minimal. To date, we have not received any complaints or adverse events due to this non-compliant marking. However, in order to comply with the standard requirements, our company has proactively taken corrective and improvement measures.
- Discovering Company: Guilin Woodpecker Medical Equipment Co., Ltd.
- Manufacturing Company: Guilin Woodpecker Medical Instrument Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/guilin-woodpecker-medical-instrument-co-ltd/c34d7d40-b1a4-497b-8f90-404de0187062/