# China NMPA Product Recall - UV curing machine

Source: https://www.keypedia.com/records/china_product_recall/bestar-medical-equipment-guangzhou-co-ltd/85ad3faf-659a-4faf-b700-a306e902f326
Source feed: China

> China NMPA product recall for UV curing machine by Bestar Medical Equipment (Guangzhou) Co., Ltd. published November 22, 2018. Recall level: Level 3. Bestar Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Class III recall of its UV curing

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bestar Medical Equipment (Guangzhou) Co., Ltd. voluntarily recalls UV curing machines
- Company Name: Bestar Medical Equipment (Guangzhou) Co., Ltd.
- Publication Date: 2018-11-22
- Product Name: UV curing machine
- Recall Level: Level 3
- Recall Reason: 1) The symbols for protection against electric shock are indicated on the outside of the packaging box and in the instruction manual, but not on the product itself, which is a non-compliant location. (2) The indicator light on the power charging stand uses red, which does not meet the standard requirements. The probability of injury from these two issues is extremely low, and the risk is minimal. To date, we have not received any complaints or adverse event reports due to these non-compliant markings. However, in order to meet the standard requirements, our company has proactively taken corrective and improvement measures.
- Discovering Company: Bestar Medical Equipment (Guangzhou) Co., Ltd.
- Manufacturing Company: Bestar Medical Equipment (Guangzhou) Co., Ltd.
- Summary: Bestar Medical Devices (Guangzhou) Co., Ltd. initiated a voluntary Class III recall of its UV curing machines (Model: PM-LED04, specific batches including 18D17758-18D17808) due to non-compliance with established medical device standards. This action was reported to the National Medical Products Administration (NMPA) on November 9, 2018, with a publication date of November 22, 2018.
The primary issues identified were related to product labeling and design. Firstly, the anti-electric shock level symbol, though present on the packaging and in the instruction manual, was absent from the product body, failing to meet required placement standards. Secondly, the power charging status indicator light utilized a red color, which also did not conform to regulatory specifications. Bestar Medical Devices stated that the risk of injury from these issues was minimal, and no adverse events or complaints had been reported.
Under the regulatory oversight associated with its Guangdong Medical Device Registration Certificate, Bestar took prompt corrective actions. These included immediately notifying customers, halting further sales of the affected product batches, and implementing a recall for rectification in accordance with non-conforming product control procedures. The company completed a thorough review, identified the root cause of the non-compliance, and performed necessary rework on remaining units. Post-rework, these units were submitted to the Guangzhou Medical Device Quality Supervision and Inspection Center for re-inspection of the corrected items, ensuring adherence to quality and safety standards.

Company: https://www.keypedia.com/companies/bestar-medical-equipment-guangzhou-co-ltd/8ae3d8ae-14cf-4c33-bace-c9482add5131