BEUDAMED
    FDA Recall Terminated

    Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.

    Recall: Z-1221-2010 · Initiated November 12, 2009

    Recall

    Recall Number
    Z-1221-2010
    Event Number
    54165
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    REM
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 12, 2009
    Posted
    May 6, 2010
    Terminated
    May 11, 2010
    Address
    2345 Waukegan Rd, Bannockburn, IL, 60015-1515

    Description

    Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.

    Reason

    A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.

    Action

    A Service Note was sent to service organizations on November 12, 2009. The communication asked customers to check if they must exchange their shutters and send their planned exchange date by 2009-11-20 to [email protected]. Customers were also asked to check the serial numbers of the one-wire chips of the shutters. Then lastly, the were asked to exchange the shutters and confirm the exchange.

    Distribution

    Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.

    Quantity

    15 microscopes and 8 spare part shutters