Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).
FDA device recall Z-0307-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
- Action taken
- A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 208
- Distribution
- Worldwide, including USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South
- Date initiated
- 2006-11-10
- Date posted
- 2006-12-27
- 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.