Recall Z-0598-2007 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) base; Model 801763.
| Date | Jun 30, 2007 (initiated Nov 1, 2005) |
| Status | Terminated |
| Reason | The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional. |
| Root cause | Other |
| Action | Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available. |
| Quantity | 485 of both model numbers |
| Distribution | Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia. |
| 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 |