23

May

2024

FDA Recall: Installed Unreleased Software Resulting in Incorrect Visual Feedback

0

Company: Stryker Leibinger GmbH & Co. KG
Date of Enforcement Report: 5/23/2024
Class II

PRODUCT

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.

Recall Number:

Z-1885-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Stryker Leibinger GmbH & Co. KG

VOLUME OF PRODUCT IN COMMERCE:

705 units

DISTRIBUTION:

US Nationwide distribution.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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