Recall Z-0050-2025 · OLO Orthopedic Stereotaxic Instrument

Medtronic Navigation, Inc.

StealthStation 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.

Date	Oct 10, 2024 (initiated Aug 22, 2024)
Status	Open, Classified
Reason	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.
Root cause	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: 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 wit
Quantity	1,801 systems
Distribution	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, AUSTRIA, BAHRAIN, BANGLADESH,
FDA record	Open on fda.gov

510(k) clearances named in this recall

K201189

Stealthstation S8 Spine Software v1.3.0
Medtronic Navigation, Inc., May 29, 2020