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SpiroAir
Medi Soft SA · Model SpiroAir DLCO-He IB · UDI-DI 05407003163018
1
510(k) clearances
31
Adverse events
1
Recalls
93
Facilities
Description
Rolling seal Spirometer, intended for measuring lung volumes by spirometry and Helium dilution
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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Get your free API keyRead the docsData 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.