{ "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": "104235", "product_res_number": "Z-0208-2012", "event_date_initiated": "2011-09-26", "event_date_posted": "2011-11-17", "recall_status": "Terminated", "event_date_terminated": "2012-05-15", "res_event_number": "59990", "product_code": "DXH", "k_numbers": [ "K071995", "K081257", "K101639", "K110499" ], "product_description": "ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard, 2 Pekeris St, Rehovot, 76100, Israel; there are two models used with either the ACT 1 sensor or the ACT III sensor:\na) Model Ozone-HTC\nb) Model BlackJack2 SGH-i617\n\nLifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service.", "code_info": "Models Ozone-HTC and BlackJack2 SGH-i617, all serial numbers with software version 5.5.9", "firm_fei_number": "1000127138", "recalling_firm": "Lifewatch Services Inc", "address_1": "10255 W Higgins Rd 10255 international center ii w higgins rd", "city": "Rosemont", "state": "IL", "postal_code": "60018-5606", "additional_info_contact": "847-459-7799", "reason_for_recall": "LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, LifeWatch, sent an \" Urgent Device Recall\" letter dated September 27, 2011 to the affected customers. The letter describes the product, problem and action to be taken. The customers were instructed to immediately refrain from providing these devices to their customers; stop using the affected sensors, return their entire kit in the pre-paid mailer, and use the new device kit included with the recall letter. In addition, the letter informed the users that the replacement device has upgraded software and firmware that allows for detection of shorts in the cable, and if detected, cuts off current flow to the patient to prevent minor shocks and burns.\n\nIf you have any questions, please call (847) 813-4258.", "product_quantity": "532 phone monitors", "distribution_pattern": "Nationwide distribution.", "openfda": { "k_number": [ "K955060", "K884142", "K853096", "K923493", "K933012", "K924187", "K000775", "K944362", "K033410", "K894140", "K012012", "K082077", "K032736", "K172311", "K782076", "K830477", "K243003", "K981394", "K900541", "K972649", "K050940", "K954495", "K954350", "K250258", "K992772", "K851124", "K963811", "K820986", "K915769", "K882290", "K093976", "K973863", "K862668", "K964036", "K934975", "K894799", "K851123", "K010945", "K802089", "K840587", "K942586", "K896039", "K913400", "K052767", "K201669", "K030218", "K173872", "K023689", "K071228", "K943123", "K983026", "K864293", 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"3041276591", "3000126629", "3003708031" ], "device_name": "Transmitters And Receivers, Electrocardiograph, Telephone", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2920", "device_class": "2" } } ] }