{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "65655", "product_res_number": "Z-0286-2008", "event_date_initiated": "2007-06-13", "event_date_posted": "2007-12-20", "recall_status": "Terminated", "event_date_terminated": "2008-10-17", "res_event_number": "45499", "product_code": "HQF", "k_numbers": [ "K041598" ], "product_description": "Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.", "code_info": "Solitaire-DGS P/N 303896 (serial # /system #): 31577 /4A2149, 32263 /4A2150, 32256 /4A2152, 32224 /4A2162, 32264 /4A2165, 32627 /4A2174D   Solitarie-SGS P/N 3038960 serial # /system #): 31313 /4A2129, 32223 /4A2148, 32728 /4A2160, 32733 /4A2175S", "recalling_firm": "Ellex USA", "address_1": "7138 Shady Oak Road", "city": "Eden Prairie", "state": "MN", "postal_code": "55344", "additional_info_contact": "952-881-9100", "reason_for_recall": "Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.", "root_cause_description": "Device Design", "action": "Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.", "product_quantity": "10", "distribution_pattern": "Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.", "openfda": { "k_number": [ "K860358", "K781965", "K834060", "K063297", "K103056", "K190448", "K832089", "K142398", "K061024", "K092621", "K170302", "K833274", "K952894", "K840854", "K201502", "K841856", "K201623", "K862987", "K893709", "K040209", "K091981", "K212630", "K123056", "K251772", "K833532", "K842412", "K990075", "K812219", "K021538", "K883213", "K043613", "K192045", "K854949", "K252979", "K960522", "K890086", "K080423", "K832316", "K926470", "K910532", "K170067", "K081774", "K220877", "K100019", "K220430", "K031665", "K203130", "K842250", "K033941", "K844358", "K020374", "K951079", "K960971", "K903421", "K062074", "K910612", "K973193", "K862568", "K121187", "K223132", "K123542", "K213592", "K852529", "K894835", "K875000", "K090774", "K031023", "K925663", "K863246", "K043236", "K130195", "K813492", "K840145", "K854288", "K140362", "K964751", "K051944", "K791659", "K091581", "K152603", "K081565", "K972514", "K103547", "K904699", "K133358", "K062624", "K231011", "K120825", "K001772", "K081946", "K140336", "K870839", "K932296", "K872846", "K864063", "K932836", "K112154", "K122202", "K782106", "K142830", "K885164", "K910805", "K842251", "K111460", "K833533", "K904366", "K013760", "K023094", "K190083", "K931784", "K050541", "K905453", "K180402", "K091534", "K100253", "K852464", "K202760", "K935747", "K900199", "K070776", "K895213", "K222157", "K222395", "K243014", "K990665", "K152688", "K833232", "K850572", "K230722", "K843965", "K853890", "K844357", "K905141", "K242397", "K881134", "K131207", "K091064", "K942180", "K882372", "K230350", "K834305", "K130933", "K220974", "K844668", "K881494", "K852234", "K971950", "K240615", "K863591", "K010372", "K111108", "K882908", "K834610", "K111643", "K893630", "K124043", "K895196", "K050807", "K782065", "K232051", "K890509", "K981196", "K841855", "K041598", "K894273", "K233911", "K873460", "K142172", "K232417", "K153769", "K181682", "K840590", "K133019", "K801336", "K973220", "K072823", "K171488", "K230228", "K251507", "K874609" ], "pma_number": [ "P990078" ], "registration_number": [ "3005350457", "2939653", "3009026057", "9680671", "3013515803", "3038356864", "1211998", "8030392", "2028159", "3004858034", "1650907", "3005012805", "9681121", "2247224", "3008156177", "3002808022", "3030860039", "8030988", "1222616", "3020611964", "3004497289", "3004467263", "3009298127", "3045817901", "3002807715", "3005941719", "1932180", "3001592626", "1920664", "3027683457", "9615745", "3015658550", "3007589150", "3010220595", "3012037425", "3016678045", "1054713", "3008252121", "2246552", "2529392", "3010849408", "1000391004", "3009337401", "3010487482", "2936921", "1047843", "3002807090", "3009462521", "1644019", "8043792", "3029221947", "9615030", "1018470", "3016405041", "3007851054", "3002991496", "1526711", "1928237", "2031962", "1313525", "3010208880", "9611516" ], "fei_number": [ "1000119305", "3005350457", "2939653", "3009026057", "3038356864", "1211998", "3004858034", "3005012805", "3002806902", "1000120916", "3030860039", "3002808022", "3002681132", "3002806863", "3004497289", "3004467263", "1317628", "3009298127", "3045817901", "3003282815", "1000121498", "3002807715", "3001592626", "3002807944", "1920664", "3027683457", "1000122089", "3003465293", "3015658550", "3007589150", "3002445546", "3002807111", "3010220595", "3012037425", "3003559308", "3008252121", "3000314405", "3016678045", "1720381", "1000125771", "2246552", "3010849408", "1000391004", "3009337401", "3010487482", "2936921", "1047843", "1000117501", "3009462521", "3029221947", "1018470", "3016405041", "3007851054", "3002991496", "1526711", "1928237", "3001362763", "3006003617", "3002808269", "1000114111", "3010208880" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }