FDA-Device2018-09-19Class II

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Vascular Technology, Inc.
Hazard

Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

Sold states
US Distribution to state of: CA.
Affected count
10 units
Manufactured in
12 Murphy Drive, N/A, Nashua, NH, United States
Products
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3026-2018

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