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Recall Observatory FDA recall evidence

Device product

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

Z-0176-2019

September 13, 2018

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 81070
Status
Terminated
Classification
Class II
Quantity
152
Official record key
device-enforcement:Z-0176-2019

Official wording

Reason: The service manual was not updated at the time of the release of software version 1.30.

Code information: All systems. UDI 00886799000588

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The service manual was not updated at the time of the release of software version 1.30.