FDAApril 4, 2024device
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 Electr...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
stryker leibinger gmbh co kgstrykerstryker leibinger
UPCs
07613327514179
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System2026-05-06
- FDAPediatric care bed; Product Designation: KayserBett IDA;2026-05-04
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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