Recalls / —

—#43983

Product

Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.

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 0031 through 1188.

Why it was recalled

The pump may stop during the autodose delivery without completion of the dose delivery to the patient.

Root cause (FDA determination)

Other

Action the firm took

Service technicians were notified on 9/30/05 to upgrade the software on these units by March 31, 2006 as follows: pump software to version 1.20, power manager software to version 1.20 and monitor software to version 2.2.1. U.S. software has all been upgraded and international upgrades are ongoing as of 7/7/06.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern

Nationwide, and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.

Timeline

Recall initiated

2005-09-01

Posted by FDA

2006-07-27

Terminated

2008-06-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.