BEUDAMED
    FDA Recall Terminated

    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

    Recall: Z-0039-2012 · Initiated August 12, 2011

    Recall

    Recall Number
    Z-0039-2012
    Event Number
    59316
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    IDO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 12, 2011
    Posted
    October 12, 2011
    Terminated
    July 25, 2013
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008

    Description

    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

    Reason

    The firm has received two complaints of finger lacerations in operators of this device.

    Action

    ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674 For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.

    Distribution

    Worldwide Distribution: Nationwide distribution; including the country of Canada.

    Quantity

    786