{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221303", "product_res_number": "Z-2856-2026", "event_date_initiated": "2026-06-19", "event_date_posted": "2026-07-31", "recall_status": "Open, Classified", "res_event_number": "99328", "product_code": "KNN", "product_description": "munevo DRIVE and munevo DRIVE r-net\n\nPowered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System", "code_info": "Affected software versions:\nmunevo DRIVE v1: 10.14.5 - 12.0.4; munevo DRIVE R-net: 10.17.5. - 12.0.4\nUDI-DI 04260691380010\n\nUnits with affected features enabled:\n2QNTGG2820170029, 2QNTGG2820170047, 2QNTGG2820160730, 2QNTGG2820161031, 1QNTGG2519120215, 1QNTGG2818520491, 1QNTGG2819210671, 2QNTGG2820160358, 2QNTGG2820170527, 2QNTGG2820160265, 2QNTGG2820160732, 1QNTGG2819200073, 2QNTGG2820160746, 2QNTGG2820160410, 2QNTGG2820160500, 2QNTGG2820160368, 2QNTGG2820161091, 2QNTGG2820161026, 2QNTGG2820160699", "firm_fei_number": "3021337381", "recalling_firm": "MUNEVO GMBH", "address_1": "Agnes-Pockels-Bogen 1 1 agnes-pockels-bogen", "city": "Munich", "country": "Germany", "reason_for_recall": "A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.", "root_cause_description": "Software Design Change", "action": "On June 19, 2026, the firm issued an \"Urgent Medical Device Recall\" letter to consignees, which detailed the hazard, mandatory boot-up safety protocols, and manual override steps.\n\nThe firm has developed software patch Version 12.1.7 (v1), and 12.2.6 (R-net)\n(released patch on June 17 2026) which corrects the profile retention database\nloop, ensuring the device consistently locks onto the last saved user profile\nduring boot. This software patch was released to all users on June 17, 2026.\n\nCustomers should update the software as soon as possible. Until the update is installed, do not activate neutral calibration in the admin menu (only applicable to those with access to the admin menu.)", "product_quantity": "19", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of California, Florida, North Carolina, Texas, Utah, and Washington. The countries of United Kingdom, Spain, Italy, Germany, and Switzerland.", "openfda": { "k_number": [ "K942312", "K883679", "K823877", "K823637", "K882253", "K861755", "K894960", "K885104", "K780192", "K915368", "K933051", "K913509", "K900839", "K925980", "K913549", "K823875", "K890178", "K942310", "K862887", "K913552", "K913548", "K812348", "K913546", "K925336", "K211919", "K913507", "K820761", "K855181", "K870299", "K923366", "K771631", "K840629", "K870698", "K921369", "K913550", "K885106", "K923364", "K884052", "K854710", "K913545", "K894770", "K923186", "K823874", "K942311", "K885105", "K915629", "K904913", "K942309", "K913511", "K813636", "K942308", "K823876", "K921027", "K861751", "K821488", "K823638", "K913553", "K882012", "K942260", "K923942", "K905013", "K861754", "K823873", "K863385" ], "registration_number": [ "3008717361", "3005660819", "3015218514", "2135139", "3007771912", "3005587124", "3017171467", "9616091", "3004111085", "3009041491", "3004905643", "3004730053", "3030822491", "3003123807", "3003636180", "3004727093", "3009567010", "3009265647", "3003823002", "3008388419", "3007923118", "3010605307", "3017526035", "3007499787", "3009303347", "3015925409", "9611742", "3007309323", "3009560891", "3008351005", "3033814356", "3012781455", "2531465", "3008485769", "3012521614", "3004473024", "9681827", "3007608806", "3003681901", "3011795161", "3039359026", "3030516433", "3044085583", "3011687503", "3023189540", "2081283", "8022890", "3033506545", "3031233916", "3005037196", "9680333", "3017607477", "3016913131", "3006534178", "3008555994", "3025369303", "3032618", "3008346606", "3004496806", "3009865268", "3006799874", "3004526603", "3008771621", "1181047", "3033433849", "3005905321", "1000109362", "3018070833", "3011000715", "3007841746", "3027643666", "3006541027", "3005191311", "3038289351", "3025309176", "3041391447", "2085336", "3013903013", "3004141004", "3012404688", "3008767869", "9613440", "3010394125", "3012958676", "3016162044", "8043392", "9616873", "3008386507", "3003820676", "3007963811", "3032597250", "9681725", "3019984611", "2085249", "3014982318", "3008058406", "3006199389", "3009407891", "3006774806", "3004452270", "1531186", "3008597995", "9618009", "3021337381", "1417592", "3009255757", "3004577612", "3008630266", "9616881", "3006703870", "3008723825", "3009421767", "3004945434", "3012316249", "3009596133", "3038986585", "3004034546", "3019677893", "3016661582", "1221084", "3012411233", "9615350", "3007649424", "3015536186", "1000292485", "3004594214", "3009303364", "3014810929", "1058069", "3003672078", "3003882673", "2937137", "3010595915", "8022752", "3007728095", "3011475060", "3034669683", "8030931", "8043717", "3044470904" ], "fei_number": [ "3008717361", "3005660819", "3015218514", "3926", "3007771912", "3005068474", "3005587124", "3017171467", "3004111085", "3009041491", "3001045529", "3004905643", "3004730053", "3030822491", "3003123807", "3002329391", "3007074101", "3003636180", "3004727093", "3009567010", "3009265647", "3003823002", "1000221992", "3002847480", "3008388419", "3007923118", "3010605307", "3017526035", "3007499787", "3009303347", "3015925409", "3007309323", "3009560891", "3008351005", "3033814356", "3012781455", "3008485769", "3012521614", "3004473024", "3009875802", "3007608806", "3003681901", "3011795161", "3039359026", "3030516433", "3044085583", "3011687503", "3023189540", "2081283", "1000334118", "3033506545", "3031233916", "3005037196", "3017607477", "3016913131", "3006534178", "3008555994", "3025369303", "3008346606", "3004496806", "3009865268", "3006799874", "3004526603", "3008771621", "1181047", "3033433849", "3005905321", "1000109362", "3003117095", "3018070833", "3011000715", "3007841746", "3027643666", "3006541027", "3003792251", "3005191311", "3038289351", "3025309176", "3003748905", "3041391447", "3013903013", "3004141004", "1000253203", "3012404688", "3008767869", "3002889431", "3010394125", "3012958676", "3016162044", "3002653226", "3008386507", "3003820676", "3007963811", "3032597250", "3019984611", "3014982318", "3008058406", "3006199389", "3009407891", "3006774806", "3004452270", "3003190528", "3008597995", "3003327839", "3021337381", "1417592", "3009255757", "3004577612", "3008630266", "3002808508", "3006703870", "3008723825", "3009421767", "3004945434", "3012316249", "3009596133", "3038986585", "3004034546", "3019677893", "3016661582", "1221084", "3012411233", "3007649424", "3015536186", "1000292485", "3004594214", "3009303364", "3014810929", "3003672078", "3003882673", "2937137", "3010595915", "1000413464", "3007728095", "3001124347", "3011475060", "3034669683", "1000306460", "3004908349", "3044470904" ], "device_name": "Components, Wheelchair", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3920", "device_class": "1" } } ] }