Recall Z-1262-06 ยท JQP Calculator/Data Processing Module, For Clinical Use
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.
| Date | Jul 27, 2006 (initiated Mar 2, 2005) |
| Status | Terminated |
| Reason | Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System. |
| 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 | 306 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.