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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DTQ
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