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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Inc.

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  Class 2 Device Recall Maquet Inc. see related information
Date Initiated by Firm October 17, 2014
Date Posted November 13, 2014
Recall Status1 Terminated 3 on April 06, 2016
Recall Number Z-0211-2015
Recall Event ID 69557
510(K)Number K102726  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Cardiohelp-I System

Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough 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 90410803 90410984 90410456 90410609 90410610 90410740 90410737 90410738 90410733 90410865 90411005 90410552 90410572 90410849 90410864 90410867 90410796 90410481 90410319 90410328 90411176 90410988 90410703 90410431 90411186 90411188 90411191 90410800 90410611 90410669 90410517 90410692 90410499 90410500 90410739 90410612 90410714 90410759 90410771 90410430 90410276 90410576 90410482 90410749 90410774 90410859 90410860 90410863 90411088 90411082 90411087 90411091 90411089 90410866 90411144 90410970 90411023 90411033 90411038 90411032 90410974 90410962 90410455 90410448 90410449 90411175 90410524 90411007 90410353 90410433 90410435 90410770 90410785 90410440 90410932 90410968 90410732 90411035 90411028 90410736 90410249 90410410 90410411 90411169 90411157 90410963 90411078 90410237 90410284 90410786 90410772 90410922 90411093 90411192 90411193 90410582 90410516 90410662 90410666 90410664 90410665 90410235 90411189 90411187 90411154 90411179 90411178 90410580 90410596 90410599 90410651 90410646 90410735 90410787 90410839 90410851 90410848 90410852 90410845 90411105 90411143 90411145 90411141 90410530 90410584 90410607 90410575 90410581 90410498 90410756 90410936 90410663 90410909 90410746 90410744 90410450 90410606 90410979 90411004 90411009 90411006 90411010 90410398 90410400 90410399 90410713 90410973 90410351 90410352 90410840 90410242 90410252 90410239 90410426 90410427 90410754 90410503 90410518 90411008 90410573 90410577 90410585 90410668 90410408 90410409 90410653 90410961 90410982 90411174 90410568 90410406 90410640 90410644 90410534 90410537 90410780 90411146 90411181 90411184 90411108 90411107 90411171 90410986 90411003 90410716 90410638 90410717 90411036 90411037 90410847 90410231 90410458 90410779 90410783 90411168 90411170 90410975 90410782 90410846 90410838 90410650 90410608 90410844 90410745 90410980 90410777 90410930 90410278 90410355 90410389 90410989 90410277 90410520 90410964 90410734 90410929 90410927 90410832 90410595 90410532 90410535 90410529 90410969 90411026 90410514 90410519 90410778 90410933 90410928 90411194 90411196 90410453 90411086 90411104 90410842 90410758 90410452 90410985 90410422 90410423 90410670 90410407 90410600 90410850 90411034 90411002 90410256 90410983 90410931 90410752 90410776 90410321 90410413 90410702 90410976 90410523 90410700 90410405 90410454 90410457 90410521 90410551 90410711 90410706 90410742 90410743 90410921 90410925 90411182 90411183 90411185 90411090 90411106 90411155 90411156 90410571 90410446 90410480 90410784 90411092 90410526 90410501 90410533 90410550 90410698 90410841 90410987 90410253 90410234 90411011 90411001 90411012 90411024 90410857 90410858 90411180 90410350 90410981 90410656 90410788 90410795 90411148 90411149 90410232 90410271 90410536 90410924 90410336 90410340 90410459 90410926 90410934 90411190 90410522 90410760 90410251 90410484 90411147 90411197 90411198 90410977 90411025 90411027 90410515 90410843 90410527 90410086 90410747 90410748 90410923 90410978 
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Karen LeFevre
973-709-7652
Manufacturer Reason
for Recall		 Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
FDA Determined
Cause 2		 Software Design Change
Action Maquet Inc. sent a Product Recall Urgent Medicall Device Field Correction letter to all of their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter stated that a software upgrade will be performed by an authorized Maquet Service Technician. A Maquet representative will contact customer to schedule an on-site service of the device. Any questions can be directed to the local Maquet representative or Maquet Customer Service at 1-888-627-8383 (option 2, option 2) Monday through Friday, between the hours of 8:00 am and 6:00 pm (EST).
Quantity in Commerce 331 units
Distribution Worldwide Distribution - US Nationwide
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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