Recall Z-3057-2011 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Inc.
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 The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
| Date | Aug 22, 2011 (initiated Jun 20, 2011) |
| Status | Terminated |
| Reason | HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction. |
| Root cause | Device Design |
| Action | Maquet sent an URGENT PRODUCT RECALL NOTIFICATION letter dated June 17, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge receipt of the notification by completing and sending back the attached response form whether or not they have any affected product, fax to 973-807-9210 no later than June 30, 2011. For any questions customers were instructed to contact thier local MAQUET representative. |
| Quantity | 229 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943803 | JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM Janus Biomedical, Inc., Jan 30, 1996 |