Recall Z-0311-2007 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 | Dec 27, 2006 (initiated May 1, 2004) |
| Status | Terminated |
| Reason | The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated. |
| Root cause | Other |
| Action | U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded. |
| Quantity | 159 |
| Distribution | Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea 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 |