Recall Z-0494-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110.
| Date | Feb 14, 2007 (initiated Oct 16, 2006) |
| Status | Terminated |
| Reason | The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it. |
| 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 | 806 |
| 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 |