—#48746

Product

Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (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 0055.

Why it was recalled

The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.

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 #48746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.