Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Recall Initiated
- September 13, 2018
- Terminated
- November 18, 2019
- Recall Number
- Z-0176-2019
- Quantity
- 152
- Firm Location
- Ann Arbor, MI
Reason for Recall
The service manual was not updated at the time of the release of software version 1.30.
Distribution
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.
Lot / Code Info
All systems. UDI 00886799000588
Root Cause
Error in labeling
Action Taken
Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.