Recalls / —

—#48749

Product

Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110.

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 0023 through 0026, 0034, 0041, 0051, 0060, 0063 through 0065, 0067 through 0069, 0071 through 0089, 0091 through 0139, 0141 through 0242, 0246 through 0280, 0282 through 0297, 0299 through 0323, 0325 through 0393, 0395 through 0421, 0423 through 0436, 0440 through 0469, 0471 through 0530, 0532 through 0550, 0552 through 0569, 0571 through 0578, 0582 through 0661, 0664 through 0666, 0668 through 0731, 0734 through 0794, 0796 through 0807, 0813 through 0817, 0820 through 0857 and 0859 through 0896.

Why it was recalled

The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.

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 #48749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.