FDA Device

Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.

Hazard

Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.

What You Should Do

Remedy

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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Products

Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
Brand
Radiometer America Inc
UPC
Model 914-317 Radiance Basic Kit. Version 2.42 operating software

Units Affected

306 units

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