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MIR MEDICAL INTERNATIONAL RESEARCH SPA · Model Spirolab PLUS · UDI-DI 08052990320554

BZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Desktop base spirometer for lung function testing

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.