Recall Z-0603-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
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 | Jun 30, 2007 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | The power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor) |
| Root cause | Other |
| Action | The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when replacement components become available. |
| Quantity | 534 of both model numbers |
| Distribution | Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa. |
| 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 |