Medtronic Navigation, Inc.: Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Recall number

Z-1776-2024

Recalling firm

Medtronic Navigation, Inc.

Product

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Status

Open, Classified

Initiated

2024-03-26

Posted

2024-05-09

Terminated

not on file

Reason

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Root cause

Software design

Action

On April 10, 2024, Medtronic Navigations, Inc. issued an Urgent: Medical Device Correction to affected consignees via UPS. In addition to informing consignees about the issue, Medtronic asked consignees to take the following actions: 1. Please review this information with all physician users. If you have any questions related to this issue, please contact Medtronic Technical Services for help at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com. 2. Please confirm via the enclosed confirmation form that this notification has been communicated within your facility with all physician users. Send the completed Customer Confirmation Form to Medtronic via email at neuro.quality@medtronic.com. a. Medtronic will work expeditiously with your facility to coordinate a software update at no charge to resolve this anomaly. 3. Pass this notice on to 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. 4. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic. Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail). Call FDA at (800) FDA-1088. Call Medtronic Technical Services at 1-888-826-5603.

Quantity

3286 applications.

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Lot, serial or model codes

UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

510(k) numbers

["K162309"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1000517638

Firm city

Lafayette

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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