# China NMPA Product Recall - Surgical navigation system, neurosurgical navigation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/ad64b6f7-76b9-4caa-89e6-b3045d655d31/
Source feed: China

> China NMPA product recall for Surgical navigation system, neurosurgical navigation system by Medtronic (Shanghai) Management Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall, announced on Decem

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. has initiated a voluntary recall of its surgical navigation systems and neurosurgical navigation systems.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Surgical navigation system, neurosurgical navigation system
- Recall Level: Level 3 Recall
- Recall Reason: Inaccurate depth measurement in neurosurgical applications (version 2.2.0 and above) may cause the biopsy needle to be inserted too deeply, resulting in biopsies of healthy brain tissue or damage to critical structures.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall, announced on December 5, 2018, for its surgical navigation systems (Registration Certificate No.: 20163542291) and neurosurgical navigation systems (Registration Certificate No.: 20173546129). The recall was prompted by an identified issue within the neurosurgical application software (version 2.2.0 and above), where the biopsy depth gauge function displays inaccurate information. This inaccuracy occurs when users utilize the navigation projection function and set it to a planned length. The primary concern is that this defect could lead to the biopsy needle being inserted too deeply, potentially causing unintended biopsy of healthy brain tissue or damage to critical anatomical structures during surgical procedures. The action was reported under the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (recall 2018-287), requiring Medtronic to recall affected products to mitigate potential patient risks associated with the software malfunction.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/