Recall Z-0439-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
| Date | Feb 14, 2007 (initiated Oct 16, 2006) |
| Status | Terminated |
| Reason | The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared. |
| Root cause | Other |
| Action | Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06. |
| Quantity | 1,951 |
| Distribution | Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, 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 |