Recall Z-2746-2017 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
| Date | Jun 26, 2017 (initiated May 10, 2017) |
| Status | Terminated |
| Reason | Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures. |
| Root cause | Software in the Use Environment |
| Action | Medtronic sent an Urgent - Product Advisory Notice dated May 10, 2017, to all affected customers. Instructions indicated that a Medtronic representative will be in contact to update the system with version 26 and will remove any copies of the Spine Tools Install CD, version 25. Please quarantine any copies of version 25 until they can be removed. If you have further questions regarding this communication, please contact your local Medtronic Navigation Technical Services Representative, your local Medtronic Spine Sales Representative, or call (800 595-9709. |
| Quantity | 108 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Brazil, Germany, Switzerland and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |