Recall Z-1286-06 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).
| Date | Jul 27, 2006 (initiated Oct 19, 2005) |
| Status | Terminated |
| Reason | While on battery power, the system may flash a low battery warning even though the battery is adequately charged. |
| Root cause | Other |
| Action | Customers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded. |
| Quantity | 329 |
| Distribution | Nationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey 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 |