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U.S. Department of Health and Human Services

Class 2 Device Recall VTI 8 MHz Surgical Doppler

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 Class 2 Device Recall VTI 8 MHz Surgical Dopplersee related information
Date Initiated by FirmJune 19, 2018
Create DateSeptember 12, 2018
Recall Status1 Terminated 3 on January 30, 2020
Recall NumberZ-3026-2018
Recall Event ID 80527
510(K)NumberK031091 
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
ProductVTI 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.  
FEI Number 1221072
Recalling Firm/
Manufacturer		 Vascular Technology, Inc.
12 Murphy Drive
Nashua NH 03062-1903
For Additional Information Contactsame
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
ActionThe 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 Commerce10 units
DistributionUS Distribution to state of: CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DPW
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