Recall Z-0294-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
| Date | Dec 19, 2006 (initiated Jan 1, 2004) |
| Status | Terminated |
| Reason | The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable. |
| Root cause | Other |
| Action | U.S. consignees were visited by firm representatives between January 2004 and September 2005 and the device modified to correct the problem. Approximately 32 exported units are still in need of being upgraded. |
| Quantity | 199 units |
| Distribution | Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand 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 |