Recall Z-0325-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
| Date | Dec 30, 2006 (initiated Oct 12, 2004) |
| Status | Terminated |
| Reason | Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen. |
| Root cause | Other |
| Action | U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed. |
| Quantity | 4,740 for all affected products |
| Distribution | Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |