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U.S. Department of Health and Human Services

Class 2 Device Recall CARDIOHELPi

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 Class 2 Recall
CARDIOHELPi
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on August 22, 2013
Recall Number Z-1149-2013
Recall Event ID 64641
Premarket Notification
510(K) Number
K102726 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Code Information Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
Recalling Firm/
Manufacturer
Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne, New Jersey 07470-2094
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Phillip Freed
973-709-7498
Manufacturer Reason
for Recall
It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action MAQUET sent an Urgent Medical Device Field Correction letters dated March 7, 2013 via Federal Express to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers are asked to complete and submit the included Customer Fax-back Form. Maquet Service will exchange all affected products with the updated version. For questions MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 2).
Quantity in Commerce 154 units affected
Distribution Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.
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 = MAQUET CARDIOPULMONARY AG
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