Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041.
FDA device recall Z-1403-06 · posted 2006-08-22 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
- Action taken
- The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- Recalls Z-1403-1405-2006- 1,135 systems in the U.S. plus 723 internationally.
- Distribution
- Worldwide-USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thai
- Date initiated
- 2006-06-30
- Date posted
- 2006-08-22
- Date terminated
- 2008-06-19
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |