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Terminated

ActiveCare DVT 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

FDA Recall Z-0387-2012 · Posted 2012-01-11

Recall StatusTerminated
Product CodeJOW
Date Initiated2011-08-28
Date Terminated2012-07-11
Product Quantity2217 units

Reason for Recall

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 DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual, the ActiveCare DVT

Firm 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].

Root Cause

Device Design

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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