FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Recall number
- Z-0176-2019
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Status
- Terminated
- Initiated
- 2018-09-13
- Posted
- not on file
- Terminated
- 2019-11-18
- Reason
- The service manual was not updated at the time of the release of software version 1.30.
- Root cause
- Error in labeling
- Action
- Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.
- Quantity
- 152
- Distribution
- US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
- Lot, serial or model codes
- All systems. UDI 00886799000588
- 510(k) numbers
- ["K172220"]
- 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