# China NMPA Product Recall - Surgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/brainlab-ag/d8ea07c1-f1cd-4c88-83d0-0f1791fdee79/
Source feed: China

> China NMPA product recall for Surgical navigation system by Brainlab AG. published September 30, 2010. Recall level: . Brainlab AG, a medical device manufacturer, initiated a recall for its Surgical Navigation System, m

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Surgical Navigation Systems
- Company Name: Brainlab AG.
- Publication Date: 2010-09-30
- Product Name: Surgical navigation system
- Recall Reason: Manufacturing defects at the interface between the camera and the camera mount reduce the stability of the camera unit, which may cause the camera unit to tip over at a certain angle during operation.
- Discovering Company: Boyilai (Beijing) Medical Equipment Trading Co., Ltd.
- Manufacturing Company: Brainlab AG.
- Summary: Brainlab AG, a medical device manufacturer, initiated a recall for its Surgical Navigation System, model Kolibri 2.0. The recall report, submitted to the National Medical Products Administration (NMPA) on August 30, 2010, and published on September 30, 2010, addressed a significant manufacturing defect. The primary issue was an instability in the interface between the camera and its bracket, which could cause the camera unit to tip over during surgical operations. This defect impacted four units of the Kolibri 2.0 model distributed across Mainland China and Hong Kong. Brainlab (Beijing) Medical Equipment Trading Co., Ltd., the responsible unit in China, managed the recall process. Under the NMPA's regulatory framework for medical devices, Brainlab AG is required to perform a corrective action. This action involves providing free-of-charge replacement of the faulty connecting component to all affected customers to ensure the safety and functionality of the surgical navigation system during use.

Company: https://www.globalkeysolutions.net/companies/brainlab-ag/889110b2-c1a6-4de4-a76f-f199191ca476/