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.
This recall has been terminated (originally issued August 29, 2011).
- Company
- Maquet Inc.
- Recall Initiated
- June 20, 2011
- Posted
- August 29, 2011
- Terminated
- October 16, 2012
- Recall Number
- Z-3084-2011
- Quantity
- 299 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.