{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "38777", "product_res_number": "Z-0806-05", "event_date_initiated": "2005-04-28", "event_date_posted": "2005-05-12", "recall_status": "Terminated", "event_date_terminated": "2006-09-01", "res_event_number": "31934", "product_code": "MKJ", "k_numbers": [ "K002232" ], "product_description": "Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E", "code_info": "Serial numbers 201887, 204213, 205309, 205857, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 206073, 206075, 206076, 206077, 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206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206640, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206702, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711", "firm_fei_number": "1418729", "recalling_firm": "MRL, Inc., A Welch Allyn Company", "address_1": "1000 Asbury Dr Ste 17 1000 Asbury Dr", "address_2": "Ste 17", "city": "Buffalo Grove", "state": "IL", "postal_code": "60089-4551", "additional_info_contact": "Mr. Huy Doan\n847-520-0300", "reason_for_recall": "The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.", "root_cause_description": "Device Design", "action": "Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.", "product_quantity": "597", "distribution_pattern": "Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.", "openfda": { "k_number": [ "K982710", "K042404", "K051632", "K883584", "K962359", "K040438", "K981802", "K123881", "K012766", "K032439", "K955882", "K033896", "K052161", "K033642", "K120406", "K860676", "K993533", "K122839", "K955923", "K954957", "K133441", "K990762", "K063510", "K052465", "K040479", "K892005", "K992977", "K982992", "K041459", "K131494", "K013425", "K110526", "K142803", "K984582", "K110154", "K030898", "K072233", "K040256", "K882067", "K023854", "K981737", "K100565", "K061707", "K972418", "K990106", "K062233", "K133484", "K081828", "K013896", "K983393", "K150198", "K892065", "K932931", "K020288", 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