Recall Z-1266-06 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.
| Date | Jul 27, 2006 (initiated Sep 1, 2005) |
| Status | Terminated |
| Reason | The pump may stop during the autodose delivery without completion of the dose delivery to the patient. |
| Root cause | Other |
| Action | Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06. |
| Quantity | 1898 combined |
| Distribution | Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey 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 |