BEUDAMED
    FDA Recall Terminated

    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.

    Recall: Z-2114-2013 · Initiated June 26, 2013

    Recall

    Recall Number
    Z-2114-2013
    Event Number
    65852
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    GKL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 26, 2013
    Posted
    August 28, 2013
    Terminated
    February 28, 2017
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.

    Reason

    The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.

    Action

    Siemens sent an Urgent Device Correction Letter dated June 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the ADVIA 120 system displays a problem when raising and supporting the optics cover, immediately contact your service provider to arrange to have the cover struts serviced. If the optics cover will not stay in the up position, as required, do not perform maintenance procedures on the optics area until the hood struts have been replaced. Siemens field support will be proactively replacing the optics cover hood struts on a regular preventive maintenance cycle based on the age of the system. Please forward this notification to whomever you may have distributed this product We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support. This response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Device Correction dated June 2013 regarding Optics Cover Struts (SMN 10309266). Please read each question and indicate the appropriate answer. Fax this completed form to Siemens Healthcare diagnostics at the fax number indicated at the bottom of this page. PLEASE FAX THIS COMPLETED FORM TO THE TECHNICAL SOLUTIONS CENTER AT (302) 631-7597.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.

    Quantity

    Domestic: 950 units; Foreign: 3369 units