Z-0176-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- September 13, 2018
- Termination Date
- November 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152
Product Description
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Reason for Recall
The service manual was not updated at the time of the release of software version 1.30.
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.
Code Information
All systems. UDI 00886799000588