FDA recall Z-0176-2019

Terumo Cardiovascular Systems Corporation · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2018-09-13
Report date
2018-10-24
Termination date
2019-11-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2019