PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 29, 2024 Initiated: April 4, 2024 #Z-1885-2024

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.

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.

Details

Units Affected
705 units
Distribution
US Nationwide distribution.
Location
Freiburg Im Breisgau

Frequently Asked Questions

What product 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.. Recalled by Stryker Leibinger GmbH & Co. KG. Units affected: 705 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1885-2024.

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