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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 29, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on April 05, 2004
Recall Number Z-0067-04
Recall Event ID 27433
510(K)Number k011465  k951189  k011465  k951189  k011465  k951189  
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product Synchron CX4, CX5 and CX9 Pro Systems.
Code Information NA
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd
Brea CA 92821
For Additional Information Contact Kathleen Jaker
Manufacturer Reason
for Recall
Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
FDA Determined
Cause 2
Action Product Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
Quantity in Commerce 351
Distribution Nationwide and Canada
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 = JQP and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = JQP and Original Applicant = BECKMAN INSTRUMENTS, INC.