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U.S. Department of Health and Human Services

Class 2 Device Recall Transonic Hemodialysis Monitor

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  Class 2 Device Recall Transonic Hemodialysis Monitor see related information
Date Initiated by Firm February 17, 2015
Date Posted March 18, 2015
Recall Status1 Terminated 3 on May 31, 2016
Recall Number Z-1295-2015
Recall Event ID 70647
510(K)Number K960817  
Product Classification System, hemodialysis, access recirculation monitoring - Product Code MQS
Product Transonic Hemodialysis Monitor, Model HD03 --
Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
Code Information Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901
Recalling Firm/
Manufacturer		 Transonic Systems Inc
34 Dutch Mill Rd
Warren Road Business Park
Ithaca NY 14850-9785
For Additional Information Contact David Klementowski
607-257-5300
Manufacturer Reason
for Recall		 Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
FDA Determined
Cause 2		 Process control
Action Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326.
Quantity in Commerce Domestic: 21 units, Foreign: 10 units
Distribution Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
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 = MQS and Original Applicant = TRANSONIC SYSTEMS, INC.
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