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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Device Recall Terumo APS 1see related information
Date Initiated by FirmOctober 12, 2004
Date PostedDecember 30, 2006
Recall Status1 Terminated 3 on February 01, 2007
Recall NumberZ-0332-2007
Recall Event ID 36396
510(K)NumberK022947 
Product Classification Perfusion System - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114.
Code Information Serial numbers 00019 through 00034, 00036, 00037, 00046 through 00053, 00055 through 00069, 00073 through 00114, 00116 through 00128, 00131 through 00193, 00195 through 00203, 00205 through 00334, 00339 through 00355, 00357 through 00414, 00416 through 00431. 00434, 00435, 00439 through 00447, 00448 through 00466, 00468 through 00473, 00475 through 00477, 00479 through 00582, 00584 through 00590, 00592 through 00594 and 00606.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionU.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.
Quantity in Commerce4,740 for all affected products
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTQ
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