Recall Z-0211-2015 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass
| Date | Nov 13, 2014 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power |
| Root cause | Software Design Change |
| Action | Maquet Inc. sent a Product Recall Urgent Medicall Device Field Correction letter to all of their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter stated that a software upgrade will be performed by an authorized Maquet Service Technician. A Maquet representative will contact customer to schedule an on-site service of the device. Any questions can be directed to the local Maquet representative or Maquet Customer Service at 1-888-627-8383 (option 2, option 2) Monday through Friday, between the hours of 8:00 am and 6:00 pm |
| Quantity | 331 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |