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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 Systemsee related information
Date Initiated by FirmApril 18, 2019
Create DateMay 15, 2019
Recall Status1 Terminated 3 on May 20, 2020
Recall NumberZ-1337-2019
Recall Event ID 82630
510(K)NumberK172220 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Code Information All
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information ContactTerumo Customer Service
800-521-2818
Manufacturer Reason
for Recall		The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
FDA Determined
Cause 2		Process control
ActionThe firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 5. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using their Terumo System 1 with EGPS, with the required backup external mechanical flowmeter, while waiting for this correction. Customers with questions are directed to the following: Terumo CVS Customer Service: 1.800.521.2818 Monday - Friday 8 a.m. to 6 p.m. ET Recall Fax: 1.734.741.6149
Quantity in Commerce1258
DistributionWorldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, 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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