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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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 Class 2 Device Recall Terumo Advanced Perfusion System 1see related information
Date Initiated by FirmJuly 26, 2013
Date PostedAugust 14, 2013
Recall Status1 Terminated 3 on February 07, 2017
Recall NumberZ-1969-2013
Recall Event ID 65354
510(K)NumberK022947 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductTerumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
Code Information Catalog number: 801764
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer Reason
for Recall		The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
FDA Determined
Cause 2		Software design
ActionTerumo CVS, sent an URGENT MEDICAL DEVICE RECALL notification letter dated July 26, 2013, to all affected customers explaining the correction to the operators manual, potential hazards and what to do in response to the issue. If you have any questions or concern please contact Terumo CVS Customer Service 1-800-521-2818 Recall Fax 1-734-741-6149 Customer Service Hours: Monday  Friday, 8 AM - 6 PM ET
Quantity in Commerce1657
DistributionWorldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
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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