Class 2 Device Recall APS 1

• Date Initiated by Firm: September 01, 2005
• Date Posted: July 27, 2006
• Recall Status: Terminated on June 11, 2008
• Recall Number: Z-1266-06
• Recall Event ID: 34488
• 510(K)Number: K022947
• Product Classification: extracorporeal circulation - Product Code DTQ
• Product: Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.
• Code Information: Serial numbers 0031 through 1188.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
• FDA Determined Cause: Other
• Action: Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.
• Quantity in Commerce: 1898 combined
• Distribution: Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.
• 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