# China NMPA Product Recall - Surgical shadowless lamp

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-jishun-medical-device-manufacturing-co-ltd/28da1905-ecc4-4428-8da7-81fc56e598b8/
Source feed: China

> China NMPA product recall for Surgical shadowless lamp by Shanghai Jishun Medical Device Manufacturing Co., Ltd. published November 16, 2021. Recall level: Level 3 Recall. Shanghai Jishun Medical Device Manufacturing Co., Ltd. initiated a voluntary Class III recall of its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Jishun Medical Device Manufacturing Co., Ltd. has voluntarily recalled its surgical shadowless lamps.
- Company Name: Shanghai Jishun Medical Device Manufacturing Co., Ltd.
- Publication Date: 2021-11-16
- Product Name: Surgical shadowless lamp
- Recall Level: Level 3 Recall
- Recall Reason: The central illuminance of the surgical shadowless lamp meets industry standards but does not meet the requirements of section 2.4 in the company's product technical requirements.
- Discovering Company: Shanghai Jishun Medical Device Manufacturing Co., Ltd.
- Manufacturing Company: Shanghai Jishun Medical Device Manufacturing Co., Ltd.
- Summary: Shanghai Jishun Medical Device Manufacturing Co., Ltd. initiated a voluntary Class III recall of its surgical shadowless lamps following a national sampling inspection conducted on April 8, 2021. The inspection, overseen by the National Medical Products Administration (NMPA), identified a critical non-compliance issue with the company's product.

Specifically, the central illuminance of the affected surgical shadowless lamps, while meeting general industry standards, did not adhere to the more stringent internal specifications outlined in Section 2.4 of the company's own product technical requirements. This discrepancy prompted Shanghai Jishun Medical Device Manufacturing Co., Ltd. to take corrective action, leading to the recall. The affected products are identified under Registration Certificate No.: 

This action highlights the importance of manufacturers not only complying with national regulations but also ensuring their products consistently meet their own established technical benchmarks. The company is required to provide detailed information on the specific models, specifications, and batches of the recalled devices via a "Medical Device Recall Incident Report Form." The NMPA, as the overarching regulatory body, disseminated this recall information to ensure public awareness and facilitate appropriate responses from healthcare providers and consumers. The recall was officially published on November 16, 2021.

Company: https://www.globalkeysolutions.net/companies/shanghai-jishun-medical-device-manufacturing-co-ltd/271e4c7e-1494-4c14-8a66-590f4920a121/