—#35720

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.

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 bearing serial numbers 20 through 109.

Why it was recalled

The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.

Root cause (FDA determination)

Other

Action the firm took

Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.

Recalling firm

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

Distribution

Distribution pattern: United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Japan, Korea, Singapore and United Kingdom.

Timeline

Recall initiated: 2003-08-12
Posted by FDA: 2004-11-18
Terminated: 2005-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.