Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
FDA device recall Z-0666-05 · posted 2005-03-31 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
- Action taken
- Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Distribution
- Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, Thailand and United Arab Emirates.
- Date initiated
- 2005-03-17
- Date posted
- 2005-03-31
- Date terminated
- 2005-09-16
- Location
- Ann Arbor, MI
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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 |