—#48579

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 00023 through 00026, 00034, 00041, 00051, 00060, 00063 through 00065, 00067 through 00069, 00071 through 00089, 00091 through 00139, 00141 through 00242, 00246 through 00280, 00282 through 00297, 00299 through 00323, 00325 through 00410 and 00419.

Why it was recalled

Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.

Root cause (FDA determination)

Other

Action the firm took

U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-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: 2004-10-12
Posted by FDA: 2006-12-30
Terminated: 2007-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.