Medical device recalls Moderate risk

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref recalled over labeling errors

Recall date
June 19, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Vascular Technology, Inc. recalls VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascu…
Recall number
Z-3026-2018
FDA classification
Class II
Brand / firm
Vascular Technology, Inc.
Sold / distributed
US Distribution to state of: CA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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