Recall Z-0923-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
| Date | Jun 30, 2007 (initiated Apr 1, 2004) |
| Status | Terminated |
| Reason | A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease. |
| Root cause | Other |
| Action | The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur. |
| Quantity | 525 total for both models |
| Distribution | Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore 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 |