Recall Z-3084-2011 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 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.
| Date | Aug 29, 2011 (initiated Jun 20, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 299 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 |