—#48736

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 0500.

Why it was recalled

Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2006-10-16
Posted by FDA: 2007-02-14
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.