Medical Device Recall: 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 hig
Stryker Leibinger GmbH & Co. KG · April 4, 2024
Reason for Recall
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.
Product Description
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
705 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1885-2024
Status: ongoing
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