BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-3026-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3026-2018
    Event ID
    80527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2018
    Initiation Date
    June 19, 2018
    Classification Date
    September 12, 2018
    Termination Date
    January 30, 2020
    Address
    12 Murphy Drive, N/A, Nashua, NH, 03062-1903, United States

    Description

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

    Reason

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

    Code Info

    Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.

    Distribution

    US Distribution to state of: CA.

    Quantity

    10 units