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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 Device Recall Maquet HL Console for Heart Lung Machine HL20 see related information
Date Initiated by Firm June 20, 2011
Date Posted August 29, 2011
Recall Status1 Terminated 3 on October 16, 2012
Recall Number Z-3084-2011
Recall Event ID 59577
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 NJ 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		 Device 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 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 = JANUS BIOMEDICAL, INC.
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