# China NMPA Product Recall - Cranial Treatment Guidance System (Neurosurgery), Spine Treatment Guidance System (Spinal Surgery), and ENT Treatment Guidance System (ENT Surgery)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-navigation-inc/48eabd84-bc45-442a-bfa9-a6cc1b36c7c8/
Source feed: China

> China NMPA product recall for Cranial Treatment Guidance System (Neurosurgery), Spine Treatment Guidance System (Spinal Surgery), and ENT Treatment Guidance System (ENT Surgery) by Medtronic Navigation Inc. published May 22, 2024. Recall level: Level 1 Recall. Medtronic Navigation, Inc., in cooperation with Medtronic (Shanghai) Management Co., Ltd., has initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Navigation, Inc. is voluntarily recalling its neurosurgical navigation systems, spinal surgery navigation systems, and otolaryngological (ENT) surgical navigation systems.
- Company Name: Medtronic Navigation Inc.
- Publication Date: 2024-05-22
- Product Name: Cranial Treatment Guidance System (Neurosurgery), Spine Treatment Guidance System (Spinal Surgery), and ENT Treatment Guidance System (ENT Surgery)
- Recall Level: Level 1 Recall
- Recall Reason: Software malfunctions may cause incorrect biopsy needle depth limit settings.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Navigation Inc.
- Summary: Medtronic Navigation, Inc., in cooperation with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class I recall impacting its neurosurgical, spinal surgery, and otolaryngology surgical navigation systems. This action, announced on May 22, 2024, addresses a critical software malfunction that may result in incorrect biopsy needle depth settings during procedures. The affected devices operate under National Medical Device Registration Certificate No. 20183010507. The National Medical Products Administration (NMPA) oversees this recall, with a Class I designation indicating the potential for serious adverse health consequences or death due to the defect. Medtronic is actively withdrawing these products from the market to mitigate risks, and specific details regarding models and batches are available in the associated recall report form.

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