Recall Z-1776-2024 ยท HAW Neurological Stereotaxic Instrument
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.
| Date | May 9, 2024 (initiated Mar 26, 2024) |
| Status | Open, Classified |
| 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 physicia |
| 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, Gua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software Medtronic Navigation, Inc., Mar 31, 2017 |