FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
- Recall number
- Z-0294-2007
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
- Status
- Terminated
- Initiated
- 2004-01-01
- Posted
- 2006-12-19
- Terminated
- 2007-02-02
- Reason
- The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
- Root cause
- Other
- Action
- U.S. consignees were visited by firm representatives between January 2004 and September 2005 and the device modified to correct the problem. Approximately 32 exported units are still in need of being upgraded.
- Quantity
- 199 units
- Distribution
- Worldwide, including USA, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
- Lot, serial or model codes
- Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
- 510(k) numbers
- ["K022947"]
- 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