{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217668", "product_res_number": "Z-1436-2026", "event_date_initiated": "2025-10-13", "event_date_posted": "2026-02-20", "recall_status": "Open, Classified", "res_event_number": "98127", "product_code": "KZF", "product_description": "MRI LED Mobile Exam Light Battery REF SL-111\n\nThis non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light", "code_info": "Model Number: SL-111\nUDI-DI code: Pending Information\nSerial/Lot Numbers:\n23-12-074\n23-12-039\n\n0\n2006001\n2006002\n2006004\n2006005\n2006006\n2006007\n2006008\n2006009\n2006011\n2006012\n2006013\n2006014\n2006015\n2006016\n2006017\n2006018\n2006020\n2006021\n2006023\n2006024\n2006026\n2006027\n2006028\n2006029\n2006030\n2006031\n2006031\n2006032\n2006033\n2006034\n2006035\n2006038\n2006039\n2006040\n2006043\n2204028\n2204047\n2206001\n2206003\n2206004\n2206005\n2206006\n2206009\n2206010\n2206011\n2206012\n2206013\n2206014\n2206015\n2206016\n2206017\n2206018\n2206019\n2206020\n2206021\n2206022\n2206024\n2206026\n2206027\n2206029\n2206030\n2206033\n2206034\n2206036\n2206037\n2206038\n2206040\n2206042\n2206043\n2206044\n2206045\n2206046\n2206048\n2206049\n2206050\n2206052\n2206053\n2206054\n2206055\n2206056\n2206057\n2206058\n2206059\n2206060\n2206062\n2206063\n2206064\n2206065\n2206066\n2206067\n2206068\n2206069\n2206070\n2206071\n2206072\n2206073\n2206074\n2206075\n2206076\n2206077\n2206079\n2206080\n2206081\n2206082\n2206083\n2206084\n2206085\n2206086\n2206087\n2206088\n2206090\n2206092\n2206093\n2206094\n2206095\n2206096\n2206097\n2206098\n2206099\n2206100\n2301228\n2311040\n2311058\n2312001\n2312002\n2312003\n2312004\n2312005\n2312006\n2312007\n2312008\n2312009\n2312010\n2312011\n2312012\n2312013\n2312014\n2312015\n2312016\n2312018\n2312019\n2312020\n2312021\n2312022\n2312023\n2312024\n2312025\n2312026\n2312027\n2312029\n2312030\n2312031\n2312033\n2312034\n2312035\n2312036\n2312036\n2312037\n2312038\n2312039\n2312041\n2312041\n2312042\n2312044\n2312045\n2312047\n2312049\n2312050\n2312051\n2312052\n2312053\n2312054\n2312055\n2312056\n2312057\n2312058\n2312059\n2312060\n2312061\n2312062\n2312064\n2312065\n2312066\n2312067\n2312068\n2312070\n2312071\n2312072\n2312074\n2312075\n2312076\n2312077\n2312078\n2312079\n2312080\n2312080\n2312081\n2312082\n2312082\n2312083\n2312084\n2312087\n2312089\n2312090\n2504001\n2504003\n2504004\n2504005\n2504006\n2504007\n2504008\n2504010\n2504011\n2504013\n2504014\n2504015\n2504016\n2504017\n2504018\n2504021\n2504022\n2504025\n2504026\n2504029\n2504030\n2504031\n2504032\n2504035\n2504036\n2504038\n2504039\n2504040\n2504044\n2504047\n2504049\n2504050\n2504051\n2504054\n2504055\n2504056\n2504058\n2504059\n2504068\n2504072\n2504073\n2504075\n(The serial number for this light has been confirmed as 2006025 and was switched in the records with row 312 (Evertett clinic).\n20 06 044\n2006025¿(account has confirmed serial as: 2006026 - 2006026 is listed as row 311 - Prince William Med Ctr)\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2006xxx\n2206025; 2206023\n2206089 & 2206078\n2206xxx\n2206xxx\n2206xxx\n2206xxx\n2206xxx\n2312xxx\n2312xxx\n2312xxx\n2312xxx\n2504xxx", "firm_fei_number": "3009560891", "recalling_firm": "MRIMed Inc.", "address_1": "1320 Stub Rd", "city": "Petaluma", "state": "CA", "postal_code": "94954-1122", "additional_info_contact": "Isabella Husary\n707-762-8600", "reason_for_recall": "Due to battery component overheating while charging resulting in melting of internal components and causing smoke.", "root_cause_description": "Under Investigation by firm", "action": "On or about 10/13/2025, the firm called customers and emailed an \"URGENT MEDICAL DEVICE QUARANTINE\" Letter to customer and distributers informing them that the firm has become aware of the possibility of the battery overheating during charging, resulting in melting of the internal components.\n\nCustomers and Distributors are instructed to:\n1. Immediately discontinue use of the battery.\n2. Do not charge the battery.\n3. Remove the charger from the battery.\n4. Label the battery and the light as BATTERY IN QUARANTINE, DO NOT USE \n5. Keep the batteries in a secure location to avoid unintended use, and await further\ninstructions from MRI Med.\n\nFor Distributors are instructed to cease distribution of the affected products.\n\nFor Questions - contact MRI Med, Inc. Monday through Friday, 8:00am-3:00pm, PST, or email sales@MRImed.com or via phone at 707-762-8600", "product_quantity": "314 batteries", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA, MA, TX, OH, NY, NC, IA, WA, TN, NJ, MO, LA, MN, AZ, VA, SC, KY, FL, MD, IN, AK, WI, NM, DC, RI, CT, CO, OK, DE, NE, MD, IL, NH and the countries of Germany, Canada.", "openfda": { "k_number": [ "K800230", "K932719", "K925710", "K931197", "K954943", "K896962", "K812142", "K922278", "K931646", "K893807", "K936088", "K851742", "K921493", "K800067", "K893808", "K780628", "K861289", "K952835", "K922150", "K901706", "K842135", "K941869", "K931026", "K924447", "K933564", "K945507", "K852949", "K922281", "K920103", "K922277", "K896611", "K934259", "K922282", "K931645", "K940284", "K922280", "K935832" ], "registration_number": [ "", "9611500", "3010373530", "3006252153", "9611503", "3031563141", "3005527904", "3027847726", "3010419931", "3012436530", "1000379039", "3010373494", "1926681", "2031963", "3010160370", "3009791213", "9680168", "9680506", "1000153536", "3021562244", "9710055", "3035678069", "3001408183", "3009715914", "8030607", "3030516433", "3012588399", "3015223105", "3033011342", "3014073090", "1316463", "3008294339", "3001124136", "3012421607", "3032109", "3003768277", "3003969012", "9617655", "3035641086", "3006087789", "3023808059", "8010482", "3000126629", "1000279762", "1836161", "3006437518", "3016678045", "3011778089", "1062917", "9681407", "3011077581", "3044829820", "3012165496", "3007143268", "3010958655", "3007583774", "3021329660", "8010153", "3013394987", "3011910987", "1000312377", "1523530", "3042279037", "8010573", "3000268902", "3011659880", "1043572", "1225473", "3013188547", "3013566770", "3005652389", "1825014", "3014326859", "3041276591", "3020887108", "3009560891", "3005934371", "3006799849", "3013783488", "3028172072", "3004009431", "3009542956", "1724810", "9710585", "3021839632", "9613910", "9610612", "1066635", "3006223081", "3033536319", "3009061550", "1000122786" ], "fei_number": [ "3006509795", "", "3010373530", "3001239142", "3006252153", "3031563141", "3005527904", "1000292048", "3027847726", "3010419931", "3012436530", "1000379039", "3010373494", "1926681", "3010160370", "3009791213", "1000153536", "3021562244", "3003057333", "3035678069", "3001408183", "3009715914", "3030516433", "3012588399", "1000125341", "3006125657", "3015223105", "3001104093", "3033011342", "3014073090", "1316463", "3008294339", "3001124136", "3002808335", "3012421607", "3002975342", "3001238683", "3003969012", "3035641086", "3006087789", "3023808059", "1000295034", "3000126629", "1000279762", "3002806315", "3006437518", "3016678045", "3004846435", "3011778089", "3003779679", "3002465150", "3011077581", "3044829820", "3012165496", "3002750084", "3007143268", "3010958655", "1000396729", "3007583774", "3021329660", "3013394987", "3011910987", "1000312377", "3002807880", "3001237319", "1523530", "3042279037", "3000268902", "3011659880", "1043572", "3004574120", "3013188547", "3013566770", "1000182014", "1825014", "3014326859", "3041276591", "3020887108", "3009560891", "3002939620", "3005934371", "3006799849", "3013783488", "3028172072", "3004009431", "3009542956", "3003169291", "3006223081", "3033536319", "3009061550", "3003184737", "1000122786" ], "device_name": "Device, Medical Examination, Ac Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.6320", "device_class": "1" } } ] }