# China NMPA Product Recall - Surgical shadowless lamp

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/3577308f-6d2c-4e2c-9fee-e562d7752bee/
Source feed: China

> China NMPA product recall for Surgical shadowless lamp by Maikewei (Shanghai) Medical Equipment Co., Ltd. published May 13, 2019. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of specific mo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary recall of its surgical shadowless lamps.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2019-05-13
- Product Name: Surgical shadowless lamp
- Recall Level: Level 2 Recall
- Recall Reason: The coating on the curved arm of certain models of surgical lights may crack, and coating particles may fall onto the patient's surgical site, posing a risk of infection.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of specific models of its surgical shadowless lamps, as reported by the National Medical Products Administration (NMPA) on May 13, 2019. The company's products are regulated under the Shanghai Food and Drug Administration's medical device registration (No. 2019-106). The manufacturer discovered a critical quality issue where the coating on the curved arm of certain surgical shadowless lamps could crack. This defect poses a risk as coating particles might fall onto a patient's surgical site, potentially leading to infection. The affected products are identified under Registration Certificate No. 20142545956. Detailed information on the specific models, specifications, and batch numbers impacted is available in the accompanying "Medical Device Recall Event Report Form." Maikewei (Shanghai) Medical Equipment Co., Ltd. confirmed they had not received any complaints or adverse event reports related to this issue at the time of the recall. This voluntary action highlights the company's proactive approach to patient safety and compliance with NMPA regulatory standards.

Company: https://www.globalkeysolutions.net/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9/