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HELION

VIDEOMED SRL · Model 116001 · UDI-DI 00615521031602

FTA Prescription

510(k) clearances

373

Adverse events

Recalls

Facilities

Description

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB SSD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..

Recalls

Date	Firm	Reason
2023-03-17	Steris Corporation	Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i
2023-03-17	Steris Corporation	Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i
2017-10-13	Ecolab, Inc.	Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
2007-02-13	Sunnex Inc.	Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
2007-02-13	Sunnex Inc.	Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.