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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/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd
Brea CA 92821
For Additional Information Contact Kathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		 Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
FDA Determined
Cause 2		 Other
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.
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