Stryker Leibinger GmbH & Co. KG recalls 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solutio…

Recall date

April 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1885-2024

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

US Nationwide distribution.

Why it was recalled

Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.