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U.S. Department of Health and Human Services

Class 2 Device Recall Radiance STAT Analyzer Management System

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 Class 2 Device Recall Radiance STAT Analyzer Management Systemsee related information
Date Initiated by FirmMarch 02, 2005
Date PostedJuly 27, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall NumberZ-1262-06
Recall Event ID 35699
Product Classification diagnostic test results report software - Product Code JQP
ProductRadiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
Code Information Model 914-317 Radiance Basic Kit. Version 2.42 operating software
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact
440-871-8900
Manufacturer Reason
for Recall		Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
FDA Determined
Cause 2		Other
ActionThe firm initiated this recall with letters to their customers on 3/2/2005. After this notification, the firm''s Field Service Reps visited each affected customer and updated their software to version 2.42. According to the firm, these actions took place from 3/12/2005 thru 4/15/2005. The Field Reps. of Radiometer America reported to Radiometer Medical ApS in Denmark that the necessary corrections had been competed as of: 4/15/2005.
Quantity in Commerce306 units
DistributionNationwide.
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.
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