Recall Z-1005-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).
| Date | Jul 7, 2007 (initiated Jul 1, 2004) |
| Status | Terminated |
| Reason | Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional. |
| Root cause | Other |
| Action | As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem |
| Quantity | 728 pumps of all models |
| Distribution | Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.