BEUDAMED
    FDA Recall Terminated

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

    Recall: Z-0119-2007 · Initiated August 4, 2006

    Recall

    Recall Number
    Z-0119-2007
    Event Number
    35934
    Firm
    Michigan Instruments, Inc.
    FEI Number
    1821850
    Product Code
    DRM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2006
    Posted
    November 3, 2006
    Terminated
    December 6, 2006
    Address
    4717 Talon Court S.E., Grand Rapids, MI, 49512-5408

    Description

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

    Reason

    Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures

    Action

    Consignees were sent a letter dated 8/4/06 with additional instructions for use. A second letter was sent on 9/1/06 to correct the new instructions provided in the first letter for page 19 of the instructions.

    Distribution

    Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.

    Quantity

    1100