Recall Z-3026-2018— Vascular Technology, Inc.

Name: FDA recall Z-3026-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-19

Class II · Terminated

Class II FDA medical device recall by Vascular Technology, Inc., initiated 2018-06-19, terminated 2020-01-30. It names one FDA 510(k) clearance: K031091. Product: 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.

Recalling firm: Vascular Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-19
Terminated: 2020-01-30
Firm location: Nashua, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K031091 — VTI 20 MHZ GATED DOPPLERVascular Technology Incorporated·cleared 2003-04-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.