BEUDAMED
    FDA Recall Terminated

    Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

    Recall: Z-0887-2009 · Initiated September 29, 2008

    Recall

    Recall Number
    Z-0887-2009
    Event Number
    50230
    Firm
    Regenesis Biomedical Inc
    FEI Number
    3003070149
    Product Code
    ILX
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    September 29, 2008
    Posted
    January 26, 2009
    Terminated
    July 8, 2009
    Address
    1435 N Hayden Rd, Scottsdale, AZ, 85257-3773

    Description

    Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

    Reason

    In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.

    Action

    Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.

    Distribution

    WY, VA, and NC

    Quantity

    7 units