FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
- Recall number
- Z-0599-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
- Status
- Terminated
- Initiated
- 2005-11-01
- Posted
- 2007-06-30
- Terminated
- 2009-06-23
- Reason
- The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
- Root cause
- Other
- Action
- Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
- Quantity
- 485 of both model numbers
- Distribution
- Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.
- Lot, serial or model codes
- Serial numbers 0006 through 0066 and 0100 through 0171 may be affected. Serial numbers 0031, 0060, 0105, 0106, 0138, 0142 and 0149 have been corrected and the other serial numbers listed will be corrected.
- 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