{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194099", "product_res_number": "Z-1308-2022", "event_date_initiated": "2022-05-06", "event_date_posted": "2022-06-30", "recall_status": "Open, Classified", "res_event_number": "90305", "product_code": "FSY", "k_numbers": [ "K130513" ], "product_description": "VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP\nARD568811911 VLT600SF AIM STP\nARD568811961 VLT600DF AIM STP\nARDVST229000A VST60SF AIM\nARDVST229001A VST60DF AIM\nARDVST229002A VST66SF AIM\nARDVST229003A VST66DF AIM\nARDVST229034A VST60SF\nARDVST229036A VST66SF\nARDVST229037A VST66DF", "code_info": "Product Code\tUDI \tProduct Description\nARD568811901\tN/A\tVLT600SF AIM STP\nARD568811911\tN/A\tVLT600SF 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"firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "additional_info_contact": "Maryanna Krivak\n973-709-7483", "reason_for_recall": "Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.", "root_cause_description": "Process change control", "action": "On May 6, 2022, the firm notified affected customers through an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily inspections per the IFU, which include checking for any chipped or missing paint. If you observe paint chipping or detachment, the firm recommends that you stop using the device and contact your Getinge service representative to schedule an appointment to replace the part free of charge. The firm is requesting that customers contact their Getinge service representative to have the part replaced if chipped or missing paint is observed through April 2025.\n\nGetinge service representatives will inspect the affected component during periodic maintenance and will replace the component if the issue is observed through April 2025.", "product_quantity": "337 (US); 8594 (OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, \nGA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.", "openfda": { "k_number": [ "K915285", "K010716", "K963682", "K140461", "K040735", "K854922", "K000639", "K002463", "K904965", "K042382", "K093009", "K120392", "K140460", "K083066", "K011693", "K982063", "K992090", "K991527", "K993242", "K914076", "K021585", "K944855", "K061317", "K132307", "K820681", "K070442", "K132747", "K100702", "K954169", "K080857", "K071698", "K961843", "K860739", "K042395", "K142076", "K981081", "K990656", "K984611", "K900211", "K093010", "K891757", "K901830", "K873786", "K060802", "K132551", "K896674", "K140812", "K780666", "K140930", "K974084", "K781887", "K965130", "K102758", "K083323", "K030906", "K024132", "K072072", "K892808", "K771865", "K973466", "K090378", "K040015", "K122875", "K974433", "K891756", "K031068", "K943288", "K031979", "K131893", "K063333", "K902864", "K101537", "K922836", "K142984" ], "registration_number": [ "3009028104", "9710098", "9681407", "3030558088", "1000122786", "3010726901", "9617655", "3012272052", "1825014", "9611503", "3025628903", "1225473", "3042992004", "1017294", "3009542956", "3011574775", "3021839632", "3007238566", "3005698350", "3000286616", "1921846", "3012165496", "3026390991", "1836161", "1054713", "3010041511", "3009129579", "3015468226", "3023808059", "9612030", "3020703842", "3011910987", "3003574554", "3011644607", "3002532594", "3027847726", "3007682310", "3007143268", "3012092534", "9710055", "1043572", "9710585", "3031563141", "3006223081", "3011137372", "8010153", "3015223105", "3017970309", "3029970239", "3031700059", "3009061550", "2031963", "3044829820", "3011580044", "3015131225", "3029936435", "3006437518", "1066635", "3035641086", "3002821232", "3030516433", "9680506", "3042970964", "1423537", "1066270", "3033527731", "3042991836" ], "fei_number": [ "3009028104", "3030558088", "3001237319", "3010726901", "1000122786", "3002957101", "3012272052", "1825014", "3002808335", "3025628903", "3001236905", "3042992004", "1017294", "3009542956", "3011574775", "1000182014", "3007238566", "1000114111", "3005698350", "3000286616", "1921846", "3012165496", "1000125341", "3026390991", "3010041511", "3006125657", "3002806934", "3009129579", "3015468226", "3023808059", "3020703842", "3011910987", "3003574554", "3011644607", "3002532594", "3027847726", "3007143268", "1000214453", "1043572", "3002750084", "3031563141", "3006223081", "3015223105", "3017970309", "3029970239", "3031700059", "3025504317", "3009061550", "3044829820", "3011580044", "3015131225", "3002975342", "3003184737", "3029936435", "3006437518", "3035641086", "3002465150", "3002821232", "3000957797", "3030516433", "3042970964", "3005747797", "3002939620", "3033527731", "3003779679", "1000396729", "3042991836" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }