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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 1see related information
Date Initiated by FirmOctober 16, 2006
Date PostedFebruary 14, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall NumberZ-0436-2007
Recall Event ID 36491
510(K)NumberK022947 
Product Classification Perfusion system - Product Code DTQ
ProductTerumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100.
Code Information Serial numbers 0036, 0045, 0047 through 0049, 0052, 0054, 0055, 0058, 0065 through 0067, 0069, 0071 through 0094, 0096 through 0254, 0256 through 0276, 0278 through 0301, 0303 through 0370, 0372 through 0376, 0378 through 0384, 0386 through 0686, 0688, 0690 through 0702, 0705 and 0706 through 0751.
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		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		Other
ActionConsignees 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 Commerce683
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DTQ
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