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U.S. Department of Health and Human Services

Class 2 Device Recall StealthStation S8

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 Class 2 Device Recall StealthStation S8see related information
Date Initiated by FirmAugust 22, 2024
Date PostedOctober 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0050-2025
Recall Event ID 95283
510(K)NumberK201189 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductStealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The 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 Information Product Number: 9735762 UDI-DI code: 00763000456986 Serial Numbers: 420002290 N06805776 N07323682 N07323683 N07323687 N07326235 N07334454 N07334475 N07338479 N07338480 N07338482 N07338929 N07354639 N07354642 N07354643 N07354644 N07354645 N07355155 N07357492 N07357493 N07360505 N07360506 N07362322 N07362323 N07364218 N07364220 N07364221 N07365158 N07365160 N07365163 N07365164 N07369302 N07369307 N07401810 N07401811 N07401812 N07401813 N07407569 N07418140 N07418141 N07426193 N07427592 N07427593 N07427597 N07428130 N07428133 N07428134 N07428190 N07428192 N07428193 N07428195 N07428197 N07429001 N07436071 N07436073 N07436074 N07438127 N07438128 N07441426 N07441431 N07448170 N07448371 N07448372 N07449575 N07460062 N07460064 N07461619 N07465933 N07469095 N07469096 N07469097 N07469100 N07469789 N07470357 N07470358 N07471822 N07471823 N07475369 N07475370 N07482977 N07505369 N07508757 N07511354 N07511355 N07511359 N07516935 N07525093 N07525094 N07525099 N07529455 N07533927 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FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
200 Medtronic Drive
Lafayette CO 80026
For Additional Information ContactRita Greenberg
612-385-3537
Manufacturer Reason
for Recall		Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. 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.
FDA Determined
Cause 2		Software design
ActionOn 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: 1.Navigation Orientation: When 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. The 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. The exam image orientation and related indication labels on the exams remain correct. Note -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. Medtronic 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. 2.Pop-up Message: When 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. Customers are instructed to: -Review Appendix A which provides detailed examples of the issues and how to identify if your system is affected. -Medtronic will work expeditiously with facilities to coordinate a software update to version 2.1 at no charge to resolve anomalies. Questions, contact Medtronic Technical Services at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.
Quantity in Commerce1,801 systems
DistributionWorldwide - 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, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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