# China NMPA Product Recall - LED surgical shadowless lamp, surgical auxiliary mobile surgical lighting

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanjing-mindray-bio-medical-electronics-co-ltd/ff616354-6fb8-42cd-bf37-241e5247f115/
Source feed: China

> China NMPA product recall for LED surgical shadowless lamp, surgical auxiliary mobile surgical lighting by Nanjing Mindray Bio-Medical Electronics Co., Ltd. published January 28, 2019. Recall level: Level 3 Recall. Nanjing Mindray Bio-Medical Electronics Co., Ltd. announced a voluntary Class III recall, effective 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanjing Mindray Bio-Medical Electronics Co., Ltd. has initiated a voluntary recall of its LED surgical shadowless lamps and surgical auxiliary mobile surgical lights.
- Company Name: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
- Publication Date: 2019-01-28
- Product Name: LED surgical shadowless lamp, surgical auxiliary mobile surgical lighting
- Recall Level: Level 3 Recall
- Recall Reason: The misalignment between the handle core and the handle disc shaft hole of the surgical light sterilization handle assembly and the internal control standard may compromise its reliability.
- Discovering Company: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
- Manufacturing Company: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
- Summary: Nanjing Mindray Bio-Medical Electronics Co., Ltd. announced a voluntary Class III recall, effective January 28, 2019, for its LED surgical shadowless lamps and surgical auxiliary portable surgical lighting. The recall was initiated due to identified potential reliability issues. Specifically, the dimensions of the handle core and handle disc shaft hole within the surgical lamp disinfection handle assembly were found to be non-compliant with the company's established internal control standards. This discrepancy could potentially affect the product's performance and safety during surgical procedures. The affected products include those with specific registration certificate codes such as "监械（准）字2014第2541133号", "苏械注准20172540033", and "苏宁械械备20140015号". Further comprehensive details, including exact models, specifications, and batch numbers, are documented in a "Medical Device Recall Event Report Form" accessible to stakeholders. This proactive measure by Nanjing Mindray demonstrates its commitment to upholding product quality and patient safety. The recall operates under the regulatory framework of the National Medical Products Administration (NMPA), which hosts the official recall notification. The Class III classification indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. This voluntary recall highlights the importance of rigorous internal quality checks and compliance with established manufacturing standards to maintain the integrity and reliability of medical devices.

Company: https://www.globalkeysolutions.net/companies/nanjing-mindray-bio-medical-electronics-co-ltd/ab63295c-0e8b-45a1-b2ea-aee876f89577/