—#48595

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
Affected lot / code info: Serial numbers 0006 through 0066 and 0100 through 0171 may be affected. Serial numbers 0031, 0060, 0105, 0106, 0138, 0142 and 0149 have been corrected and the other serial numbers listed will be corrected.

Why it was recalled

The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.

Root cause (FDA determination)

Other

Action the firm took

Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.

Timeline

Recall initiated: 2005-11-01
Posted by FDA: 2007-06-30
Terminated: 2009-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.