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U.S. Department of Health and Human Services

Class 2 Device Recall CARDIOHELPi

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  Class 2 Device Recall CARDIOHELPi see related information
Date Initiated by Firm March 07, 2013
Date Posted April 18, 2013
Recall Status1 Terminated 3 on August 22, 2013
Recall Number Z-1149-2013
Recall Event ID 64641
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 NJ 07470-2094
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		 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 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 = MAQUET CARDIOPULMONARY AG
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