Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Mana
FDA device recall Z-1262-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 306 units
- Distribution
- Nationwide.
- Date initiated
- 2005-03-02
- Date posted
- 2006-07-27
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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