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SpiroScout

Ganshorn Medizin Electronic GmbH · Model F · UDI-DI 07613365500011

BZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX)

Recalls

Date	Firm	Reason
2024-10-11	Baxter Healthcare Corporation	There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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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.