Terumo Cardiovascular Systems Corporation recalls Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Recall date
- September 13, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0176-2019
- FDA classification
- Class II
- Brand / firm
- Terumo Cardiovascular Systems Corporation
- Sold / distributed
- 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 Re…
Why it was recalled
The service manual was not updated at the time of the release of software version 1.30.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
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