Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
This recall has been terminated (originally issued October 28, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- July 6, 2006
- Posted
- October 28, 2006
- Terminated
- November 18, 2011
- Recall Number
- Z-0115-2007
- Quantity
- 5 units
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.
Distribution
Worldwide-The six USA units (equpped with Radiance software) were distributed to a total of two (2) U.S. customers: University of Missouri Hospitals and Clinics in Columbia, MO (4 units) and Vail Valley Medical Center, Vail, CO (2 units). World wide accounts pending submission. Three (3) Canadian customers. They are: 1) Seven Oaks General Hospital MB Canada; and 2) St. Mary''s General Hospital, 911 Queens Blvd, Ontario Canada; and 3) University of Alberta Hospital, 84440 112th Street, Alberta, Canada.
Lot / Code Info
Catalog Numbers: 914-418 and 914-426
Root Cause
Other
Action Taken
The recalling firm initially contacted their customers and informed them of the software problem and the upcoming field correction for the software, via telephone on 7/6/2006. A follow-up letter dated 7/21/2006, was also sent to the customers.