Device product
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Z-0176-2019
Product summary
- 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
The service manual was not updated at the time of the release of software version 1.30.