Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
This recall has been terminated (originally issued July 27, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- March 2, 2005
- Posted
- July 27, 2006
- Terminated
- February 24, 2012
- Recall Number
- Z-1262-06
- Quantity
- 306 units
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
Distribution
Nationwide.
Lot / Code Info
Model 914-317 Radiance Basic Kit. Version 2.42 operating software
Root Cause
Other
Action Taken
The 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.
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