Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
8000-021-002 Recalled by Stryker Leibinger GmbH & Co. KG Due to Unreleased software was installed on customer systems resulting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Leibinger GmbH & Co. KG directly.
Affected Products
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.
Quantity: 705 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Leibinger GmbH & Co. KG
Stryker Leibinger GmbH & Co. KG has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report