StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine s

FDA device recall Z-0050-2025 · posted 2024-10-10 · Open, Classified

Recall details

Recalling firm

Medtronic Navigation, Inc.

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.

Action taken

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 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.

Root cause

Software design

Status

Open, Classified

Product code

OLO

Quantity affected

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,

Date initiated

2024-08-22

Date posted

2024-10-10

Location

Lafayette, CO

Related 510(k) clearances