Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2018 - (Recall #: Z-0176-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 13, 2018

Date Posted: October 24, 2018

Recall Number: Z-0176-2019

Event ID: 81070

Reason for Recall:

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

Status: Terminated

Product Quantity: 152

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.

Voluntary or Mandated:

Voluntary: Firm initiated