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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 see related information
Date Initiated by Firm June 21, 2012
Date Posted July 13, 2012
Recall Status1 Terminated 3 on June 10, 2013
Recall Number Z-2010-2012
Recall Event ID 61763
510(K)Number K022947  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1

System 1 Base, 220/240V.

The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Information Catalog number: 801764 and serial number: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and 1441.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Tracy Bellanca
734-741-6173
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 21, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Recall notice. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/ email address indicated on the form. Terumo CVS Customer Service-1-800-521-2818 Fax-1-800-292-6551. Customer Service Hours: Monday - Friday, 8 AM - 6 PM EST
Quantity in Commerce 648 units
Distribution Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, 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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