—#64427

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial numbers 0188 through 1027.

Why it was recalled

The power supply may fail to charge the batteries due to various hardware malfunctions.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam.

Timeline

Recall initiated: 2008-04-17
Posted by FDA: 2008-12-29
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64427. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.