—#207180

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K162309
Affected lot / code info: UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 200 Medtronic Drive, Lafayette, Colorado 80026

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-03-26
Posted by FDA: 2024-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207180. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.