Radiometer America Inc Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Lot Codes / Batch Numbers
Model 914-317 Radiance Basic Kit. Version 2.42 operating software
Products Sold
Model 914-317 Radiance Basic Kit. Version 2.42 operating software
Radiometer America Inc is recalling Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radianc due to Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026