Recall Z-0446-2009 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
| Date | Dec 29, 2008 (initiated Apr 17, 2008) |
| Status | Terminated |
| Reason | The power supply may fail to charge the batteries due to various hardware malfunctions. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem. |
| Quantity | 161 |
| Distribution | Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam. |
| 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 |