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U.S. Department of Health and Human Services

Class 2 Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers

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  Class 2 Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers see related information
Date Initiated by Firm June 17, 2005
Date Posted August 02, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1317-06
Recall Event ID 34953
510(K)Number K002290  K992859  K991417  K9801430  
Product Classification blood gas analyzer - Product Code CHL
Product Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
Code Information All analyzers manufactured from 1/1999-12/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vince Sigmund
800-736-0600
Manufacturer Reason
for Recall		 Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
FDA Determined
Cause 2		 Other
Action The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.
Quantity in Commerce 1635 devices
Distribution Nationwide.
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 AMERICA, INC.
510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL A/S
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