Recalls / —

—#167383

Product

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

FDA product code

DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K172220

Affected lot / code info

All systems. UDI 00886799000588

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.

Recalling firm

Firm

Terumo Cardiovascular Systems Corporation

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

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.

Timeline

Recall initiated

2018-09-13

Terminated

2019-11-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #167383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.