Recall Z-0321-2008 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
| Date | Dec 1, 2007 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition. |
| Root cause | Process control |
| Action | Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards. |
| Quantity | 16 |
| Distribution | Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong 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 |