BEUDAMED
    FDA Recall Terminated

    Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA

    Recall: Z-1404-2010 · Initiated July 27, 2009

    Recall

    Recall Number
    Z-1404-2010
    Event Number
    53031
    Firm
    Novasys Medical Inc
    FEI Number
    3003647794
    Product Code
    NVJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 27, 2009
    Posted
    April 16, 2010
    Terminated
    January 8, 2011
    Address
    39684 Eureka Dr, Newark, CA, 94560-4805

    Description

    Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA

    Reason

    Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation

    Action

    A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.

    Distribution

    US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .

    Quantity

    As of 6/12/09 there were 436 Probes at customer accounts.