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Terumo Cardiovascular Systems Corporation recalls Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Recalled October 24, 2018 · FDA recall Z-0176-2019 · Terumo Cardiovascular Systems
Hazard
The service manual was not updated at the time of the release of software version 1.30. · FDA Class II
Units
152
Sold at
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.
Description
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
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →