Recall Z-1404-06 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump 4 inch diameter; Catalog No. 801040.
| Date | Aug 22, 2006 (initiated Jun 30, 2006) |
| Status | Terminated |
| Reason | The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed. |
| Root cause | Other |
| Action | The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06. |
| Quantity | Recall Numbers Z-1403-1405-2006 -1,135 systems in the U.S. plus 723 internationally. |
| Distribution | Worldwide-USA, 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 |