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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System see related information
Date Initiated by Firm September 13, 2018
Create Date October 18, 2018
Recall Status1 Terminated 3 on November 18, 2019
Recall Number Z-0176-2019
Recall Event ID 81070
510(K)Number K172220  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Terumo¿ Advanced Perfusion System 1 Electronic Patient
Gas System, Catalog#: 801188
Code Information All systems. UDI 00886799000588
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact Terumo CVS Customer Service
800-521-2818
Manufacturer Reason
for Recall		 The service manual was not updated at the time of the release of software version 1.30.
FDA Determined
Cause 2		 Error in labeling
Action Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.
Quantity in Commerce 152
Distribution US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
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 Corporation
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