BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.

    Recall: Z-2423-2010 · Initiated May 5, 2010

    Recall

    Recall Number
    Z-2423-2010
    Event Number
    55763
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 5, 2010
    Posted
    September 15, 2010
    Terminated
    October 25, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.

    Reason

    Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.

    Action

    Siemens issued an Urgent Field Safety Notice in May 2010 to customers with information on what to do if the battery leaks, overheats, or vents an odor. Firm also issued a Support Bulletin to field service personnel to inspect and replace affected units.

    Distribution

    Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland.

    Quantity

    228 units