{ "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": "112662", "product_res_number": "Z-0124-2013", "event_date_initiated": "2012-09-13", "event_date_posted": "2012-10-27", "recall_status": "Terminated", "event_date_terminated": "2015-07-10", "res_event_number": "63139", "product_code": "MKJ", "k_numbers": [ "K041067", "K052465" ], "product_description": "HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106\n\nProduct Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs:\nUnconsciousness\nNot breathing\nWithout circulation", "code_info": "Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106", "firm_fei_number": "3004123209", "recalling_firm": "Heartsine Technologies, Limited", "address_1": "203 Airport Road West", "city": "Belfast", "country": "United Kingdom", "reason_for_recall": "Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit", "root_cause_description": "Device Design", "action": "HeartSine sent an Urgent: Medical Device Recall dated September 2012 to all affected customers. The letter identifed the affected product, problem and actions to be taken. A response form was included with the letter to be completed by customers and returned to the recalling firm's representative. In addition, HeartSine is providing a software upgrade to bring all users up to a more recent version of the software. For questions call 1-877-877-0147 or your service representative.The company issued an\nadditional press release on September 13, 2013 in a further attempt to reach out to end customers that\nhad not yet responded to the companys efforts.", "product_quantity": "81,982 in total", "distribution_pattern": "Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.", "openfda": { "k_number": [ "K102496", "K010214", "K011901", "K130684", "K000638", "K110742", "K003565", "K984582", "K896919", "K002232", "K150055", "K990106", "K131550", "K973486", "K133659", "K051632", "K883341", "K020984", "K041883", "K932028", "K991007", "K052316", "K870622", "K103186", "K991910", "K955854", "K965117", "K934692", "K020743", "K010207", "K980857", "K131525", "K142430", "K981737", "K002806", "K014157", "K952101", "K063375", 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