FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.
- Recall number
- Z-1405-06
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.
- Status
- Terminated
- Initiated
- 2006-06-30
- Posted
- 2006-08-22
- Terminated
- 2008-06-19
- Reason
- The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
- Root cause
- Other
- Action
- 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.
- Quantity
- Recall Numbers 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, Thailand and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 0020 through 0216.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28