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U.S. Department of Health and Human Services

Class 2 Device Recall Radiance Flex Blood Gas Anayzer

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  Class 2 Device Recall Radiance Flex Blood Gas Anayzer see related information
Date Initiated by Firm July 06, 2006
Date Posted October 28, 2006
Recall Status1 Terminated 3 on November 18, 2011
Recall Number Z-0115-2007
Recall Event ID 36539
510(K)Number K050869  
Product Classification Blood Gas Analyzer - Product Code JQP
Product Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer
Code Information Catalog Numbers: 914-418 and 914-426
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact
440-871-8900
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 5 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JQP and Original Applicant = RADIOMETER MEDICAL APS
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