Reported May 29, 2024 · Ongoing
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation…
Stryker Leibinger GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Leibinger GmbH & Co. KG · Botzinger Str. 41 · Freiburg Im Breisgau · N/A
Is this the product you have?
- 8000-021-002, Scopis¿ ENT Software with TGS¿
- with Sofware VersionNOVA 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
- Lot codes and dates
- Sofware VersionNOVA 3.6.0 RC16
- Product Code8000-021-002
- UDI/DI07613327514179
- Serial Numbers
551 of 551 codes
109841011010164104541076210387101201025210414106121040810673110131103210566109740310-B103261044210729106811055210088104761030710121103710252-B1026210602106131038110234200774101350304-B1030310257106391044510684107401098610413100791052810565104821020910574106061022910214107970335-B102841046510295103080282-B
- Amount recalled
- 705 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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