—#48592

Product

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; 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: Serial numbers 0011 through 0039 and 0041 through 0170.

Why it was recalled

The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.

Root cause (FDA determination)

Other

Action the firm took

U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.

Timeline

Recall initiated: 2004-05-01
Posted by FDA: 2006-12-27
Terminated: 2007-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.