{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "141498", "product_res_number": "Z-0563-2016", "event_date_initiated": "2015-11-02", "event_date_created": "2015-12-31", "recall_status": "Completed", "res_event_number": "72542", "product_code": "FSY", "k_numbers": [ "K061317", "K102758" ], "product_description": "Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5", "code_info": "4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)", "firm_fei_number": "3003184737", "recalling_firm": "Trumpf Medical Systems, Inc.", "address_1": "1046 Legrand Blvd", "city": "Charleston", "state": "SC", "postal_code": "29492-7672", "additional_info_contact": "Chandler Sprinkles\n843-329-0543", "reason_for_recall": "The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.", "root_cause_description": "Other", "action": "TRUMPF sent an \" Urgent Field Safety Information\" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nActions to be taken by the customer:\n\n1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee.\n\nSigns that indicate a possible fall of the spring arm:\n\nThe movement of the light and spring arm is difficult for the user,\nThe lights have stopped being operational, and/or\nA gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example).\n\n2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. \n\nIf you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359", "product_quantity": "20,713", "distribution_pattern": "USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.", "openfda": { "k_number": [ "K892808", "K914076", "K100702", "K973466", "K990656", "K021585", "K943288", "K961843", "K904965", "K072072", "K142076", "K132307", "K896674", "K093009", "K122875", "K854922", "K131893", "K974084", "K083066", "K140461", "K024132", "K060802", "K102758", "K974433", "K860739", "K781887", "K132747", "K944855", "K030906", "K891756", "K132551", "K042395", "K040015", "K090378", "K101537", "K071698", "K873786", "K820681", "K120392", "K140460", "K002463", "K982063", "K891757", "K070442", "K142984", "K900211", "K902864", "K000639", "K771865", "K080857", "K040735", "K011693", "K140812", "K963682", "K901830", "K965130", "K093010", "K140930", "K063333", "K061317", "K922836", "K984611", "K083323", "K993242", "K954169", "K992090", "K981081", "K915285", "K991527", "K042382", "K010716", "K031979", "K780666", "K031068" ], "registration_number": [ "3023808059", "3031700059", "2031963", "3011644607", "3025628903", "3009061550", "3042992004", "9710585", "9617655", "3006223081", "3000286616", "1000122786", "3003574554", "3007591382", "3030516433", "3007238566", "3027847726", "3012165496", "1066635", "3009028104", "3012092534", "3029970239", "1017294", "9612030", "3030558088", "3042991836", "3012272052", "1423537", "1225473", "3009542956", "1836161", "3002821232", "3031563141", "3015468226", "1043572", "3006437518", "1066270", "9710055", "9680506", "9710098", "8010153", "3021839632", "3015223105", "3005698350", "3029936435", "3007682310", "3026390991", "3020703842", "3015131225", "3010726901", "3009129579", "3010041511", "3011580044", "3011574775", "3035641086", "3011137372", "9611503", "3011910987", "3044829820", "1054713", "3002532594", "9681407", "3033527731", "1921846", "3007143268", "1825014", "3042970964", "3017970309" ], "fei_number": [ "1000114111", "3003779679", "3023808059", "1000396729", "3005747797", "3031700059", "1000214453", "3011644607", "3002957101", "3025628903", "3009061550", "3002750084", "3042992004", "3006223081", "3001236905", "3000286616", "1000122786", "3002939620", "3003574554", "3007591382", "3030516433", "3007238566", "3002808335", "3027847726", "3012165496", "3009028104", "3029970239", "3003184737", "1017294", "3030558088", "3042991836", "3012272052", "1000125341", "3009542956", "3002975342", "3002821232", "3031563141", "3015468226", "1043572", "3006437518", "3002465150", "3001237319", "3015223105", "3005698350", "3029936435", "3026390991", "3020703842", "3015131225", "3010726901", "3009129579", "3010041511", "3011580044", "3011574775", "1000182014", "3035641086", "3000957797", "3002806934", "3011910987", "3044829820", "3025504317", "3006125657", "3002532594", "3033527731", "1921846", "3007143268", "1825014", "3042970964", "3017970309" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }