# China NMPA Product Recall - Cranial Treatment Guidance System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-navigation-inc/26cdd477-3c9f-4b7d-b924-0e5e363b95fd/
Source feed: China

> China NMPA product recall for Cranial Treatment Guidance System by Medtronic Navigation Inc. published February 11, 2019. Recall level: Level 1 Recall. Medtronic Navigation Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Navigation Inc. Changes the Recall Level of its Cranial Treatment Guidance System for Neurosurgical Navigation
- Company Name: Medtronic Navigation Inc.
- Publication Date: 2019-02-11
- Product Name: Cranial Treatment Guidance System
- Recall Level: Level 1 Recall
- Recall Reason: Our company has received complaints regarding software malfunctions, specifically alleging that the depth gauge function in the Neurosurgery Synergy Cranial application (version 2.2.0 and above) is inaccurate. Our investigation revealed that if users utilize the navigation projection function and set the projection length to be greater than the planned length, the illustrated biopsy depth gauge function may display inaccurate information. This could lead to the biopsy needle being inserted too deeply, potentially resulting in biopsies of healthy brain tissue or damage to critical structures.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Navigation Inc.
- Summary: Medtronic Navigation Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class III recall for its Cranial Treatment Guidance System for Neurosurgery. The core issue, first identified in December 2018 and reaffirmed in a February 2019 supplementary report, stems from a software malfunction within the Neurosurgery (Synergy Cranial) Application Software (version 2.2.0 and above). This defect can cause the biopsy depth gauge to display inaccurate information when users set the navigation projection length greater than the planned length. Such inaccuracies could lead to excessively deep biopsy needle insertion, risking damage to healthy brain tissue or critical anatomical structures. The recall affects 143 units globally, with 135 units sold in China, falling under the National Medical Products Administration (NMPA) regulatory oversight. Required actions include Medtronic issuing a recall request and customer notification letters, detailing the problem and preventative measures to mitigate patient risk. The recall currently focuses on communication and risk mitigation rather than physical product returns.

Company: https://www.globalkeysolutions.net/companies/medtronic-navigation-inc/314c41df-1248-4c0a-88d1-30388476ffd7/