Recall Z-0315-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
| Date | Dec 27, 2006 (initiated May 1, 2004) |
| Status | Terminated |
| Reason | The gas system may fail calibration prior to use due to incorrect gas system flowmeter software. |
| Root cause | Process control |
| Action | U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected. |
| Quantity | 5 |
| Distribution | Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China. |
| 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 |