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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet HL Console for Heart Lung Machine HL20

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 Class 2 Recall
Maquet HL Console for Heart Lung Machine HL20
see related information
Date Posted August 29, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-3084-2011
Recall Event ID 59577
Premarket Notification
510(K) Number
K943803 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
Code Information 510K Number: K943803 Device Listing No.E614811 HL 20 4-umps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan Mandy
201-995-8968
Manufacturer Reason
for Recall
Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
FDA Determined
Cause 2
DESIGN: Software Design
Action Maquet sent a PRODUCT RECALL NOTIFICATION LETTER/return response forms, dated June 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until a software update was performed by their trained technicians. Customers were also asked to forward the information contained in the notification letter to all users and to all appropriate Biomedical Staff. Customers were instructed to acknowledge receipt of the notification letter by completing and faxing back the attached response form to 973-807-9210 whether or not they have any of the affected product. For questions customers were instructed to contact their local MAQUET representative. For questions regarding this recall call 973-709-7994.
Quantity in Commerce 299 units
Distribution Nationwide Distribution
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 = JANUS BIOMEDICAL, INC.
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