Recalls / —
—#35719
Product
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
- 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 #35719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.