—#48583

Product

Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.

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, 00025 through 00027, 00055, 00061 through 00081, 00083 through 00099, 00101 through 00109, 00111 through 00183, 00185 through 00260, 00262 through 00269. 00271 through 00293, 00295 through 00307 and 00309 through 00357.

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 #48583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.