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U.S. Department of Health and Human Services

Class 3 Device Recall ABL800 blood gas analyzer

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  Class 3 Device Recall ABL800 blood gas analyzer see related information
Date Initiated by Firm October 31, 2005
Date Posted August 03, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1325-06
Recall Event ID 35796
510(K)Number K041874  
Product Classification blood gas analyzer - Product Code CHL
Product ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Code Information All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
Recalling Firm/
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
Manufacturer Reason
for Recall
ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
FDA Determined
Cause 2
Action The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
Quantity in Commerce 36
Distribution Worldwide, including USA and 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 = CHL and Original Applicant = RADIOMETER MEDICAL APS