Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | Terumo Cardiovascular Systems Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The service manual was not updated at the time of the release of software version 1.30. |
| Product | Terumo® Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 |
| 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,… |
| Initiated | 2018-09-13 |
| Classified | 2018-10-18 |
| Terminated | 2019-11-18 |
| Recall number | Z-0176-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Cardiovascular Systems Corporation (Z-0176-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81070/
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