Z-1262-06

Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT...

Name: Z-1262-06 Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT...
Creator: Radiometer America Inc
Published: 2005-03-02
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-03-02 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic on 2005-03-02. The reason FDA records is "Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1262-06
Status: Terminated
Initiated: 2005-03-02
Posted: 2006-07-27
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 306 units
Distribution: Nationwide.
Product codes and lots: Model 914-317 Radiance Basic Kit. Version 2.42 operating software

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)