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-0312-2007
- 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
- 2004-05-01
- Posted
- 2006-12-27
- Terminated
- 2007-02-01
- Reason
- The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
- Root cause
- Other
- Action
- U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.
- Quantity
- 55
- Distribution
- Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 0006 through 0066.
- 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