# China NMPA Product Recall - surgical microscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/e40741ae-0260-4ea7-9f53-f7eb56b94e2f/
Source feed: China

> China NMPA product recall for surgical microscope by Leica Microsystems (Shanghai) Trading Co., Ltd. published February 28, 2019. Recall level: Level 2 Recall. On February 28, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling surgical microscopes.
- Company Name: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-02-28
- Product Name: surgical microscope
- Recall Level: Level 2 Recall
- Recall Reason: If the screws connecting the rocker arm and the primary scope are not tightened sufficiently, the M220 primary scope may accidentally fall into the surgical area, causing injury to the patient.
- Discovering Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Summary: On February 28, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its surgical microscopes. This action was prompted by a critical safety concern involving insufficient tightening of screws that connect the rocker arm to the main mirror in the M220 model of these devices. The defect poses a significant risk, as it could lead to the main mirror detaching and falling into the sterile surgical field, potentially causing serious injury to patients during medical procedures. The recall, reported under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, applies to surgical microscopes identified by Registration Certificate No. 20172221149. Leica Microsystems (Shanghai) Trading Co., Ltd. is responsible for implementing this recall to address the identified product deficiency. Specific details regarding the affected product models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This measure underscores the commitment to patient safety and adherence to product quality standards within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/leica-microsystems-shanghai-trading-co-ltd/a190d1a7-ccd3-4a6e-9490-3b9fd63aa553/