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SpiroScout SP Plus
Ganshorn Medizin Electronic GmbH · Model D · UDI-DI 07613365500035
BZG
Prescription
10
510(k) clearances
31
Adverse events
1
Recalls
93
Facilities
Description
The SpiroScout SP plus is intended exclusively for use with the following SCHILLER devices. CARDIOVIT CS-104 SPIROVIT SP-1 G2 CARDIOVIT AT-102 G2 The SpiroScout SP plus is an ultrasonic measuring system which is used for pulmonary function diagnostics. It determines the transit times of the ultrasonic signals and can be used with the above-mentioned Schiller devices to measure and analyse respiratory flow and volume.
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.