StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

FDA device recall Z-1666-2023 · posted 2023-06-02 · Open, Classified

Recall details

Recalling firm

Medtronic Navigation, Inc.

Reason for recall

In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury

Action taken

On 4/11/23, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system." 2) All physician users should review the correction notice. Pass on the notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 3) Complete and return the customer confirmation form that can be returned to neuro.quality@medtronic.com. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at rs.navtechsupport@medtronic.com

Root cause

Software design

Status

Open, Classified

Product code

HAW

Quantity affected

556

Distribution

US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVO

Date initiated

2023-04-11

Date posted

2023-06-02

Location

Lafayette, CO

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