BEUDAMED
    FDA Recall Terminated

    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

    Recall: Z-1363-2016 · Initiated January 8, 2016

    Recall

    Recall Number
    Z-1363-2016
    Event Number
    72894
    Firm
    Natus Medical Incorporated
    FEI Number
    3018859
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 8, 2016
    Posted
    April 11, 2016
    Terminated
    February 10, 2017
    Address
    5900 1st Ave S, Seattle, WA, 98108-3248

    Description

    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

    Reason

    NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.

    Action

    Natus of Seattle, WA began sending the Urgent Field Safety Notice NatalCare LX Incubator letter (DOC-017939A) to consignees on 1/8/16. A repair kit to correct this issue is now available for repair of affected units. Consignees should complete the NatalCare LX Incubator Oval Port Hinge Repair Kit Order Form and FAX it 847-949-6031 or scan and email this form to [email protected]. Alternately you can telephone Natus Technical Service at 888-496-2887 and order the kit from a specialist. Natus will send the kit(s) free-of-charge to the address you specify. Each upgrade will require up to - 1 hour of time and require simple hand tools. If you have any questions, please contact Technical Service at 888-496-2887 or send email to: [email protected]

    Distribution

    Distribution US nationwide and Pakistan.

    Quantity

    75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.