Recall Z-0666-05 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
| Date | Mar 31, 2005 (initiated Mar 17, 2005) |
| Status | Terminated |
| Reason | The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode. |
| Root cause | Other |
| Action | Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded. |
| Distribution | Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, 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 |