BEUDAMED
    FDA Recall Terminated

    ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema

    Recall: Z-0386-2012 · Initiated August 28, 2011

    Recall

    Recall Number
    Z-0386-2012
    Event Number
    59812
    Firm
    Medical Compression Systems 2 Hallan St OR Aqiva Israel
    FEI Number
    3003715046
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2011
    Posted
    January 11, 2012
    Terminated
    July 11, 2012

    Description

    ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema

    Reason

    This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare+S.F.T device might cease to work if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual the ActiveCare+S.

    Action

    Medical Compression Systems (DBN) Ltd, sent out "VOLUNTARY FIELD ACTION" letters dated September 15, 2011 to all affected customers. The letter included description of the device and problem. Customers were instructed to check their inventory and make a list of serial numbers of all applicable ActiveCare+S.F.T. and ActiveCare DVT devices in their inventory, include the list on the attached excel file (Field Action Verification Form) and email to [email protected]; even if they do not have any such devices. The letter also states that within 15 days from the email, they will receive instructions for the next steps. In addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T. DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP. In case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: [email protected] or [email protected].

    Distribution

    Nationwide distribution.

    Quantity

    551 units