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U.S. Department of Health and Human Services

Class 2 Device Recall APS 1

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  Class 2 Device Recall APS 1 see related information
Date Initiated by Firm September 01, 2005
Date Posted July 27, 2006
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-1267-06
Recall Event ID 34488
510(K)Number K022947  
Product Classification extracorporeal circulation - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041.
Code Information Serial numbers 0033 through 1339.
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 2		 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 and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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