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U.S. Department of Health and Human Services

Class 2 Device Recall RADIANCE Data Management Module

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  Class 2 Device Recall RADIANCE Data Management Module see related information
Date Initiated by Firm July 28, 2014
Date Posted September 06, 2014
Recall Status1 Terminated 3 on October 15, 2014
Recall Number Z-2597-2014
Recall Event ID 68982
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product RADIANCE v. 2.4X, 2.5X and 2.6X

Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Code Information Verions 2.4X, 2.5X and 2.6X
Recalling Firm/
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information Contact Technical Support Department
440-871-8900 Ext. 209
FDA Determined
Cause 2
Software design
Action Radiometer sent an Product Notification letter dated July 31, 2014 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The letter informed customers that local RADIOMETER IT specialist will contact customers in order to schedule the upgrade to v. 2.74 or 3.5.2. All RADIANCE versions below 2.7X will be upgraded to v. 2.74 or 3.5.2. For questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt.4.
Quantity in Commerce N/A
Distribution Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
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.