Recall Z-0050-2025— Medtronic Navigation, Inc.

Name: FDA recall Z-0050-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-22

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2024-08-22. It names one FDA 510(k) clearance: K201189. Product: 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.. 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-22
Firm location: Lafayette, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K201189 — Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc.·cleared 2020-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.