FDA Medical Device Recalls (openFDA)
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 number
- Z-1262-06
- 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.
- Status
- Terminated
- Initiated
- 2005-03-02
- Posted
- 2006-07-27
- Terminated
- 2012-02-24
- 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.
- Lot, serial or model codes
- Model 914-317 Radiance Basic Kit. Version 2.42 operating software
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28