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U.S. Department of Health and Human Services

Class 2 Device Recall System 1

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  Class 2 Device Recall System 1 see related information
Date Initiated by Firm July 26, 2012
Date Posted August 21, 2012
Recall Status1 Terminated 3 on June 27, 2014
Recall Number Z-2230-2012
Recall Event ID 62684
510(K)Number K022947  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Serial interface module RS-232

Product Usage:
The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
Code Information catalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu
FDA Determined
Cause 2		 Device Design
Action Terumo sent an URGENT MEDICAL DEVICE Recall letter dated July 24, 2012 to all affected customers. The letter identified the affected product, reason for correction, potential hazard and actions to be taken. The letter stated that Terumo CVS will replace all affected modules. Customers were informed that a Terumo VS Representative will contact the user to schedule a service call for the replacement upon receipt of the Response Form attached. For questions contact Terumo CVS Customer Service at 800-521-2818.
Quantity in Commerce 579 units
Distribution Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
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 = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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