Class 2 Device Recall Radiance Flex Blood Gas Anayzer

• Date Initiated by Firm: July 06, 2006
• Date Posted: October 28, 2006
• Recall Status: Terminated 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: 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