{ "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": "142958", "product_res_number": "Z-0694-2016", "event_date_initiated": "2015-12-18", "event_date_posted": "2016-01-27", "recall_status": "Terminated", "event_date_terminated": "2016-03-24", "res_event_number": "73067", "product_code": "FDF", "k_numbers": [ "K141598" ], "product_description": "Fuse 1C Colonoscope", "code_info": "Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS, F1C0219FUSE1CS, F1C0220FUSE1CS, F1C0221FUSE1CS, F1C0222FUSE1CS, F1C0223FUSE1CS, F1C0224FUSE1CS, F1C0225FUSE1CS, F1C0228FUSE1CS, F1C0229FUSE1CS, F1C0230FUSE1CS, F1C0231FUSE1CS, F1C0232FUSE1CS, F1C0233FUSE1CS, F1C0235FUSE1CS, F1C0236FUSE1CS, F1C0237FUSE1CS, F1C0238FUSE1CS, F1C0239FUSE1CS, F1C0241FUSE1CS, F1C0243FUSE1CS, F1C0245FUSE1CS, F1C0246FUSE1CS, F1C0247FUSE1CS, F1C0248FUSE1CS, F1C0249FUSE1CS, F1C0250FUSE1CS, F1C0251FUSE1CS, F1C0252FUSE1CS, F1C0253FUSE1CS, F1C0254FUSE1CS, F1C0255FUSE1CS, F1C0256FUSE1CS, F1C0257FUSE1CS, F1C0258FUSE1CS, F1C0259FUSE1CS, F1C0261FUSE1CS, F1C0262FUSE1CS, F1C0263FUSE1CS, F1C0264FUSE1CS, F1C0266FUSE1CS, F1C0267FUSE1CS, F1C0268FUSE1CS, F1C0269FUSE1CS, F1C0270FUSE1CS, F1C0271FUSE1CS, F1C0272FUSE1CS, F1C0273FUSE1CS, F1C0274FUSE1CS, F1C0276FUSE1CS, F1C0277FUSE1CS, F1C0278FUSE1CS, F1C0279FUSE1CS, F1C0280FUSE1CS, F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS,  F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C, Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C, F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C0545FUSE1C, F1C0546FUSE1C, F1C0547FUSE1C, F1C0549FUSE1C, F1C0584FUSE1C, F1C0586FUSE1C, F1C0603FUSE1C, F1C0640FUSE1C, F1C0660FUSE1C, F1C0668FUSE1C, F1C0691FUSE1C, F1C0692FUSE1C, F1C0693FUSE1C, F1C0694FUSE1C, F1C0709FUSE1C, F1C0714FUSE1C, F1C0736FUSE1C, F1C0739FUSE1C, F1C0742FUSE1C, F1C0745FUSE1C, F1C0749FUSE1C, F1C0758FUSE1C, F1C0763FUSE1C, F1C0765FUSE1C, F1C0767FUSE1C, F1C0776FUSE1C, F1C0778FUSE1C, F1C0779FUSE1C, F1C0786FUSE1C, F1C0790FUSE1CL, F1C0791FUSE1CL, F1C0794FUSE1C, F1C0796FUSE1C, F1C0799FUSE1C, F1C0800FUSE1CL, F1C0802FUSE1C, F1C0806FUSE1C, F1C0811FUSE1C, F1C0812FUSE1C, F1C0814FUSE1C, F1C0817FUSE1C, F1C0818FUSE1C, F1C0825FUSE1C, F1C0827FUSE1C, F1C0828FUSE1C, F1C0829FUSE1C, F1C0831FUSE1C, F1C0833FUSE1C, F1C0834FUSE1C, F1C0835FUSE1C, F1C0837FUSE1C, F1C0838FUSE1C, F1C0841FUSE1C, F1C0849FUSE1C, F1C0852FUSE1C, F1C0857FUSE1C, F1C0858FUSE1C, F1C0859FUSE1C, F1C0860FUSE1C, F1C0862FUSE1C, F1C0863FUSE1C, F1C0864FUSE1C, F1C0866FUSE1C, F1C0867FUSE1C, F1C0868FUSE1C, F1C0870FUSE1C, F1C0871FUSE1C, F1C0872FUSE1C, F1C0873FUSE1C, F1C0874FUSE1C, F1C0875FUSE1C, F1C0876FUSE1C, F1C0878FUSE1C, F1C0879FUSE1C, F1C0880FUSE1C, F1C0883FUSE1C, F1C0884FUSE1C, F1C0885FUSE1C, F1C0893FUSE1C, F1C0894FUSE1C, F1C0895FUSE1C, F1C0898FUSE1C, F1C0900FUSE1C, F1C0902FUSE1C, F1C0905FUSE1C, F1C0906FUSE1C, F1C0907FUSE1C, F1C0908FUSE1C, F1C0910FUSE1C F1C0921FUSE1C; Item number: FSC330-A6334, Model number: F1C-MC90, Serial numbers: 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215 and 0700217; Item number: FDC-3300-133, Model number: Fuse Colo 133, Serial numbers: F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0203FUSE1C-133, F1C0204FUSE-133, F1C0205FUSE1C-133, F1C0206FUSE1C-133, F1C0207FUSE1C-133, F1C0208FUSE1C-133, F1C0209FUSE1C-133, F1C0210FUSE1C-133, F1C0211FUSE1C-133, F1C0216FUSE1C-133, F1C0217FUSE1C-133, F1C0218FUSE1C-133, F1C0219FUSE1C-133, F1C0221FUSE1C-133, F1C0222FUSE1C-133, F1C0223FUSE1C-133, F1C0224FUSE1C-133. F1C0225FUSE1C-133, F1C0226FUSE1C-133, F1C0227FUSE1C-133, F1C0228FUSE1C-133, F1C0229FUSE1C-133, F1C0230FUSE1C-133, F1C0235FUSE1C-133 and Item number: FSC-3300-150, Model number: Fuse Colo 150, Serial numbers: F1C0202FUSE1C-150, F1C0203FUSE1C-150, F1C0204FUSE1C-150, F1C0205FUSE1C-150, F1C0206FUSE1C-150, F1C0207FUSE1C-150, F1C0208FUSE1C-150, F1C0209FUSE1C-150, F1C0210FUSE1C-150, F1C0211FUSE1C-150, F1C0212FUSE1C-150, F1C0214FUSE1C-150.", "firm_fei_number": "3032507796", "recalling_firm": "EndoChoice, Inc.", "address_1": "11810 Wills Rd Ste 100 11810 ATTN Theron Gober", "address_2": "Ste 100", "city": "Alpharetta", "state": "GA", "postal_code": "30009-2081", "additional_info_contact": "Nigel Wilkinson\n678-708-4771", "reason_for_recall": "The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.", "root_cause_description": "Process design", "action": "Consignees were notified on12/09/2015 that a sales representative would be contacting them to facilitate the exchange of the colonsocope and the defective device will be returned to EndoChoice.", "product_quantity": "253 units", "distribution_pattern": "Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.", "openfda": { "k_number": [ "K113050", "K043487", "K173392", "K261587", "K231254", "K112391", "K230332", "K032688", "K051068", "K173085", "K063654", "K111028", "K100966", "K112680", "K230588", "K120289", "K041903", "K153483", "K810654", "K210052", "K160356", "K951580", "K232043", "K210981", "K810791", "K161791", "K220158", "K163492", "K171673", "K091783", "K244029", "K884857", "K951579", "K181437", "K051541", "K172036", "K132210", "K790338", "K130718", "K121582", "K131780", "K961570", "K131855", "K182540", "K954704", "K951574", "K943895", "K173317", "K070330", "K100624", "K242110", "K260423", "K220007", "K002749", "K081004", "K822846", "K810682", "K141286", "K792179", "K063585", "K160196", "K080317", "K213773", "K901610", "K243261", "K210851", "K191220", "K961563", "K162330", "K140595", "K160015", "K180285", "K250432", "K091305", "K232922", "K213578", "K192793", "K093037", "K052930", "K192664", "K221452", "K242325", "K951575", "K001241", "K181084", "K132839", "K223827", "K951578", "K023259", "K190669", "K180405", "K161355", "K143732", "K141598", "K190649", "K760452", "K111756", "K102616", "K192588", "K801223", "K202469", "K162428", "K970372", "K211819", "K090116", "K252457", "K083180", "K101191", "K101053", "K093187", "K162622", "K070622", "K103312" ], "device_name": "Colonoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "", "3018258446", "3015451828", "1221826", "1220477", "1000121056", "3013505983", "3002808148", "3015136743", "3013944123", "3021008900", "3003775006", "8010047", "3012843412", "1528319", "2950776", "9610877", "2011171", "3010703925", "3011816755", "3015746529", "3012414760", "3017210488", "3010202439", "3004016520", "3005099803", "3006161756", "9611680", "3004705634", "3006546082", "9614641", "3008879776", "3004052101", "2528981", "3024021261", "3020707080", "3013184907", "3042172882", "3003637092", "3004111573", "3011416394", "3011050570", "3010229237", "2246552", "9610617", "3021246306", "3010390468", "9681260", "3023102955", "3010288205", "1651395", "1047843", "3009420598", "3014605202", "3002807314", "3013023255", "3003782610", "9616684", "3005814162", "3004644065", "3042225166", "3010707607", "3028058843", "3014769442", "9611112", "1222928", "3009698186", "2020550", "3014342096", "3005261802", "3008797804", "3002808022", "3014279513", "3010009693", "3008386005", "3022106566", "9610595", "3015525240" ], "fei_number": [ "", "3018258446", "1000135740", "3015451828", "1221826", "1220477", "1000121056", "1000122656", "3002808268", "3013505983", "3002808148", "3015136743", "3013944123", "3021008900", "3003775006", "3012843412", "3002807795", "3007475226", "3008185830", "2011171", "3010703925", "3011816755", "3003995201", "3015746529", "3012414760", "3002964398", "3017210488", "3004016520", "3005099803", "3004705634", "3006546082", "3008879776", "3004052101", "2528981", "3024021261", "3020707080", "3013184907", "3042172882", "3003637092", "3004111573", "3011416394", "3011050570", "3010229237", "2246552", "3002808127", "3008782585", "3021246306", "3010390468", "3023102955", "3010288205", "1047843", "3003012447", "1000120613", "3009420598", "3014605202", "3002807314", "3013023255", "3002806565", "3003782610", "3002807969", "3005814162", "3004644065", "3042225166", "3010707607", "3028058843", "3014769442", "3009698186", "2020550", "3014342096", "3005261802", "3002913962", "3008797804", "3002808022", "3014279513", "3010009693", "3008386005", "3022106566", "3015525240" ] } } ] }