| Class 1 Device Recall Stealthstation S7 Cranial Software Version 3.1.4 | |
Date Initiated by Firm | April 11, 2023 |
Date Posted | June 02, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1630-2023 |
Recall Event ID |
92141 |
510(K)Number | K221087 |
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
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Product | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems |
Code Information |
Model/UDI-DI; Software Version: 9735585/00763000631635, 9735586/00763000631765, 9735587/00763000631826; 3.1.4 |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 200 Medtronic Drive Lafayette CO 80026
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For Additional Information Contact | Christine Stewart 720-890-3200 |
Manufacturer Reason for Recall | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury |
FDA Determined Cause 2 | Software design |
Action | On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following;
1) Do not utilize the following:
a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures.
In accordance with the IFU: 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. Always use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
b) 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 and will communicate additional information when it becomes available.
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 |
Quantity in Commerce | 746 |
Distribution | Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY.
OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HAW
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