Z-1776-2024Class I

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as...

Name: Z-1776-2024 Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as...
Creator: Medtronic Navigation, Inc.
Published: 2024-03-26
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2024-03-26 / Open, Classified / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in... on 2024-03-26. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1776-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-26
Posted: 2024-05-09
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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 tag: software
FDA 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 [email protected]. 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 [email protected]. 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 in commerce: 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.
Product codes and lots: UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1776-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1776-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-09

Product code HAW

K162309Class IIStealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. / cleared 2017-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)