| Class 2 Device Recall Terumo APS 1 | |
Date Initiated by Firm | October 12, 2004 |
Date Posted | December 30, 2006 |
Recall Status1 |
Terminated 3 on February 01, 2007 |
Recall Number | Z-0335-2007 |
Recall Event ID |
36396 |
510(K)Number | K022947 |
Product Classification |
Perfusion System - Product Code DTQ
|
Product | Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046. |
Code Information |
Serial numbers 0020 through 0025, 0030 through 0036, 0038 through 0040, 0042, 0044, 0045, 0047 through 0081, 0083, 0084, 0086 through 0102, 0106 through 0110, 0112 through 0130, 0132 through 0137, 0139 through 0147, 0149 through 0154, 0157 through 0166, 0169 through 0175 and 0177 through 0189. |
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 |
Action | 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. |
Quantity in Commerce | 4,740 for all affected products |
Distribution | 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. |
Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = DTQ
|
|
|
|