—#48735

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (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 0066 and 0100 through 0245.

Why it was recalled

A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly become zero, even when the battery is fully functional.

Root cause (FDA determination)

Other

Action the firm took

Consignees were sent a letter dated 11/10/06 informing them of the nature of the issues and that the firm would contact them to schedule a service call to install the software upgrade package. The software upgrade installation began at customers on 10/16/06, prior to issuance of the letter to consignees.

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 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 #48735. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.