BEUDAMED
    FDA Recall Terminated

    Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.

    Recall: Z-0455-2013 · Initiated May 24, 2011

    Recall

    Recall Number
    Z-0455-2013
    Event Number
    63634
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    JCX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 24, 2011
    Posted
    December 3, 2012
    Terminated
    May 28, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.

    Reason

    Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.

    Action

    Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to [email protected]. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.

    Distribution

    Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.

    Quantity

    154