Recall Z-0307-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
| Date | Dec 27, 2006 (initiated Nov 10, 2006) |
| Status | Terminated |
| Reason | Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage. |
| Root cause | Other |
| Action | A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B. |
| Quantity | 208 |
| Distribution | Worldwide, including USA, 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
This recall record lists no 510(k) number.