Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmSeptember 29, 2003
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on April 05, 2004
Recall NumberZ-0067-04
Recall Event ID 27433
510(K)NumberK011465 K951189 
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
ProductSynchron 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 ContactKathleen 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
ActionProduct Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
Quantity in Commerce351
DistributionNationwide and Canada
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 = JQP
510(K)s with Product Code = JQP
-
-