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SonoTT FlowLab
em-tec GmbH · Model 11916 · UDI-DI 04062114000013
DPW
Prescription
1
510(k) clearances
75
Adverse events
35
Recalls
43
Facilities
Description
The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-04 | Koven Technology, Inc. | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |
| 2025-09-26 | Medistim Asa | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer S |
| 2025-08-07 | Flosonics Medical (R/A 1929803 ONTARIO CORP.) | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. |
| 2023-06-19 | Baxter Healthcare Corporation | An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B |
| 2018-06-19 | Vascular Technology, Inc. | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver |
| 2017-04-25 | Medistim Asa | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
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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.