Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VTI 8 MHz Surgical Doppler

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall VTI 8 MHz Surgical Doppler see related information
Date Initiated by Firm June 19, 2018
Create Date September 12, 2018
Recall Status1 Terminated 3 on January 30, 2020
Recall Number Z-3026-2018
Recall Event ID 80527
510(K)Number K031091  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel
Ref. Number: 108910

Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Code Information Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.  
Recalling Firm/
Manufacturer		 Vascular Technology, Inc.
12 Murphy Drive
Nashua NH 03062-1903
For Additional Information Contact same
603-594-9700
Manufacturer Reason
for Recall		 Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
FDA Determined
Cause 2		 Labeling Change Control
Action The firm, Vascular Technology, Inc., "URGENT: MEDICAL RECALL DEVICE" letter dated June 18, 2018, to its customer on June 19, 2018. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine inventory and return all product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. If you have any questions, contact VP Sales person at 603-594-9700.
Quantity in Commerce 10 units
Distribution US Distribution to state of: CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DPW and Original Applicant = VASCULAR TECHNOLOGY INCORPORATED
-
-