—#48460

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. Serial numbers 0011 through 0499.

Why it was recalled

Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.

Root cause (FDA determination)

Other

Action the firm took

A letter dated 11/10/06 was sent to consignees providing them with an addendum (814576R/B) to the operators'' manual. Users of systems produced prior to May 2006 received only this addendum, but users produced between May and November 2006 had previously received addendum 814576R/A which is corrected and to be replaced by the new addendum 814576R/B.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, 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: 2006-11-10
Posted by FDA: 2006-12-27
Terminated: 2008-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.