Devices

Device Recall Radiance Flex Blood Gas Anayzer

Model / Serial
Catalog Numbers: 914-418 and 914-426
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
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.
Product Description
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Manufacturer
Radiometer America Inc
1 Event
- Recall of Device Recall Radiance Flex Blood Gas Anayzer

Manufacturer

Radiometer America Inc

Manufacturer Address
Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
Source
USFDA

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