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
FDA Recall Z-0386-2012 · Posted 2012-01-11
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Recalling FirmMedical Compression Systems
Recall StatusTerminated
Product CodeJOW
Date Initiated2011-08-28
Date Terminated2012-07-11
Product Quantity551 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+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.
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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