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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Device Recall Terumo APS 1 see related information
Date Posted February 14, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0435-2007
Recall Event ID 36491
510(K)Number K022947 
Product Classification Perfusion system - Product Code DTQ
Product Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
Code Information Serial numbers 0006 through 0066 and 0100 through 0245.
Recalling Firm/
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
Manufacturer Reason
for Recall
Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.
FDA Determined
Cause 2
Action Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
Quantity in Commerce 207
Distribution Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.