{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "209896", "product_res_number": "Z-0050-2025", "event_date_initiated": "2024-08-22", "event_date_posted": "2024-10-10", "recall_status": "Open, Classified", "res_event_number": "95283", "product_code": "OLO", "k_numbers": [ "K201189" ], "product_description": "StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)\n\nThe StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.", "code_info": "Product Number: 9735762\nUDI-DI code: 00763000456986\nSerial 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code: 00763000368494\nSerial Numbers:\nN07370801\nN07441433\nN07521588\nN08159976\nN08223525\nN08223526\nN08245859\nN11710650\nN29255594\nN29529070\nN29531246\nN29810113\nN29855918\nN29934774\nN30001599\nN30009142\nN30043574\nN30046047\nN30067122\nN30067123\nN30389711\nN30416388\nN30449098\nN30462311\nN30610820\nN30803335\nN30927583\nN30927584\nN31022442\nN31049476\nN31088569\nN31088570", "firm_fei_number": "1000517638", "recalling_firm": "Medtronic Navigation, Inc.", "address_1": "200 Medtronic Drive", "city": "Lafayette", "state": "CO", "postal_code": "80026", "additional_info_contact": "Rita Greenberg\n612-385-3537", "reason_for_recall": "Due to two software anomalies that can occur within a spine procedure. Two issues are:\n1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped).\n2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.", "root_cause_description": "Software design", "action": "On 08/22/2024, an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter was mailed to customers informing them of 2 software anomalies impacting spine procedures on the StealthStation S8 system (StealthStation S8 Basic, StealthStation S8 Plus and StealthStation S8 Premium) with Application software version 1.3.0 or 1.3.2. Issues are:\n1.Navigation Orientation:\nWhen lateral orientation radiographic images are taken using a navigation-enabled Ziehm Vision FD Vario 3D C-arm, the orientation information appears flipped when displayed by the StealthStation S8 system.\nThe navigation information is displayed with a 180-degree rotation around the superior/inferior(S/I) axis with the left/right (L/R) axis and anterior/posterior (A/P) axis appearing as mirror images.\nThe exam image orientation and related indication labels on the exams remain correct.\nNote -this anomaly only impacts StealthStation\" S8 systems where the Ziehm Vision FDVario 3D C-arm Interface Kit, 9734486, installed and calibrated on a Ziehm FD system in the lateral orientation; other orientations settings are not impacted.\nMedtronic Recommends Do not use the lateral orientation setting on the Ziehm Vision FD Vario 3D C-arm, if using the StealthStation\" S8 with software version 1.3 or 1.3.2.\n\n2.Pop-up Message:\nWhen using CT + Fluoroscopy images with a slice spacing thickness greater than 2 mm, the system does not display a pop-up message indicating the slice spacing is not optimal. Navigation remains accurate in this situation.\n\nCustomers are instructed to:\n-Review Appendix A which provides detailed examples of the issues and how to identify if your system is affected.\n-Medtronic will work expeditiously with facilities to coordinate a software update to version 2.1 at no charge to resolve anomalies.\n\nQuestions, contact Medtronic Technical Services at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.", "product_quantity": "1,801 systems", "distribution_pattern": "Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, \nAUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, \nColombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, \nFRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, \nJapan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, \nMalaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, \nROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, \nUKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.", "openfda": { "k_number": [ "K233443", "K162364", "K181449", "K233706", "K261113", "K261410", "K203679", "K211616", "K201327", "K162567", "K162921", "K152574", "K193135", "K200935", "K240625", "K151364", "K111843", "K090420", "K182982", "K260546", "K250879", "K223070", "K254157", "K240647", 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