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SonoTT Vascular Probe

em-tec GmbH · Model 11344 · UDI-DI 04062114000129

510(k) clearances

Adverse events

Recalls

Facilities

Description

High quality workmanship Ultrasonic Flow Probes for the measurement of blood flow in vessels and grafts. The probes are showing excellent accuracy and stability. Calibration data are stored in the probe. The probes can be manually and automatically cleaned and disinfected and sterilized with steam, ethylene oxide (EtO), low temperature steam and form - aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We support up to 50 sterilisation cycles

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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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.