—#43936

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); 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: All units using Power Manager software version 1.10, which includes serial numbers 6 through 156.

Why it was recalled

While on battery power, the system may flash a low battery warning even though the battery is adequately charged.

Root cause (FDA determination)

Other

Action the firm took

Customers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.

Timeline

Recall initiated: 2005-10-19
Posted by FDA: 2006-07-27
Terminated: 2008-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43936. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.