FDA-Device2018-10-24Class II
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terumo Cardiovascular Systems Corporation
Hazard
The service manual was not updated at the time of the release of software version 1.30.
Sold states
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.
Affected count
152
Manufactured in
6200 Jackson Rd, N/A, Ann Arbor, MI, United States
Products
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2019Don't want to check this manually?
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