BEUDAMED
    FDA Enforcement Class II Terminated

    120 V Neptune 3 Rover, Model Number: 0703-001-000

    Recall: Z-2630-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2630-2016
    Event ID
    74759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    August 23, 2016
    Termination Date
    June 2, 2017
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    120 V Neptune 3 Rover, Model Number: 0703-001-000

    Reason

    Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.

    Code Info

    120 V Neptune 3 Rover, Model Number: 0703-001-000; Serial Numbers: 1606300523, 1610606263, 1610903973, 1610904293, 1612303683, 1612303823, 1612303963, 1606300553, 1610606273, 1610904063, 1610904313, 1612303703, 1612303833, 1612303973, 1606300583, 1610606303, 1610904083 , 1610904343, 1612303713, 1612303843 , 1612303993, 1606300593, 1610606323, 1610904103, 1610904353, 1612303723, 1612303853 , 1613106443, 1606300613, 1610606353, 1610904123, 1610904363 , 1612303733, 1612303863, 1613106463, 1606300623, 1610619473, 1610904163, 1610904373 , 1612303743, 1612303873, 1613106583, 1606300643, 1610619483, 1610904173, 1610904403, 1612303763 , 1612303883 , 1613201233, 1606300653, 1610619543, 1610904183, 1612303633, 1612303783, 1612303903, 1613201243 , 1607503463 , 1610619573 , 1610904193, 1612303643, 1612303793, 1612303913, 1613201303, 1607503493, 1610619603 , 1610904203, 1612303663, 1612303813, 612303933, 1613201323, 1610409473, 1610903893, 1610904213, 1612303673

    Distribution

    Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None

    Quantity

    78