—#49815

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 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected.

Why it was recalled

The power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor)

Root cause (FDA determination)

Other

Action the firm took

The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when 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: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.

Timeline

Recall initiated: 2005-08-01
Posted by FDA: 2007-06-30
Terminated: 2009-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.