{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103790", "product_res_number": "Z-0387-2012", "event_date_initiated": "2011-08-28", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-07-11", "res_event_number": "59812", "product_code": "JOW", "k_numbers": [ "K023573" ], "product_description": "ActiveCare DVT\nMedical Compression Systems\nOR Aqiva, IL\n\nIntended 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", "code_info": "Device Catalog Number A502B-0001-02 and H502B-0001-07", "firm_fei_number": "3003715046", "recalling_firm": "Medical Compression Systems", "address_1": "2 Hallan St", "city": "OR Aqiva", "country": "Israel", "additional_info_contact": "Mr. Charlie Harrison\n404-229-1499", "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", "root_cause_description": "Device Design", "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 maya@mcsmed.com; 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. \n\nIn addition, the letter stated -YOU MAY CONTINUE TO USE THE ActiveCare+S.F.T. DEVICES WHILE AWAITINGTHE INSTALLATION OF THE OVP.\n\nIn case you have questions or you need any assistance, you can contact the firm at (317) 485-7887 or e-mail to: maya@mcsmed.com or mahlet@mcsmed.com.", "product_quantity": "2217 units", "distribution_pattern": "Nationwide distribution.", "openfda": { "k_number": [ "K010744", "K140092", "K950967", "K131193", "K961891", "K122499", "K250974", "K974318", "K151158", "K920308", "K122609", "K193288", "K201547", "K961166", "K992454", "K013297", "K111748", "K163620", "K053575", "K100306", "K131743", "K190975", "K012417", "K214053", "K981643", "K781358", "K110276", "K212731", "K170216", "K830577", "K232270", "K053316", "K251086", "K012614", "K132360", "K914461", "K963067", "K172030", "K250242", "K112677", "K012616", "K172103", "K863581", "K123308", "K012612", "K180389", "K193068", "K202839", "K111720", "K123647", "K141064", "K022786", "K140755", "K913611", "K933977", "K043423", "K953648", "K140813", "K122330", "K960902", "K102737", "K150980", 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