BEUDAMED
    FDA Recall Terminated

    RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.

    Recall: Z-2479-2015 · Initiated July 28, 2015

    Recall

    Recall Number
    Z-2479-2015
    Event Number
    71840
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 28, 2015
    Posted
    August 28, 2015
    Terminated
    February 17, 2017
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.

    Reason

    When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.

    Action

    Siemens Healthcare issued Urgent Field Safety Notice sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on July 28, 2015, both in the United States and outside of the United States, for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 dual port LIS transmission feature. Users are informed to: If the system is currently set up with dual LIS transmission enabled, one of the ports (either Serial or Ethernet) needs to be disabled. Instruction provided with the notification. Customer to complete Field Effectiveness Check Form to confirm receipt of the notice. The resolution of this issue will be implemented in the next software release for the RAPIDPoint 500 system. If you have any questions, contact Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed Customer Care form to (312) 275-7795.

    Distribution

    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany,Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands. New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, U.A.E., United Kingdom and Vietnam.

    Quantity

    5241 units