Class 3 Device Recall Terumo APS 1

• Date Initiated by Firm: May 01, 2004
• Date Posted: December 27, 2006
• Recall Status: Terminated on February 01, 2007
• Recall Number: Z-0311-2007
• Recall Event ID: 36398
• 510(K)Number: K022947
• Product Classification: cardiovascular perfusion system - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
• Code Information: Serial numbers 0011 through 0039 and 0041 through 0170.
• 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 battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
• FDA Determined Cause: Other
• Action: U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.
• Quantity in Commerce: 159
• Distribution: Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea 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 and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.