{ "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": "204782", "product_res_number": "Z-0713-2024", "event_date_initiated": "2023-11-28", "event_date_posted": "2024-01-11", "recall_status": "Open, Classified", "res_event_number": "93556", "product_code": "KNN", "product_description": "Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair", "code_info": "UDI-DI: 05407008320119;\nLot Numbers: 3304-3317\n3322-3329\n3440-3452\n3569-3618\n3830-3844\n4020-4054\n4170-4176\n4250-4255\n4321-4330", "firm_fei_number": "3011795161", "recalling_firm": "mo-Vis BVBA", "address_1": "Biebuyckstraat 15D 15d biebuyckstraat", "city": "Nevele", "country": "Belgium", "reason_for_recall": "In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.", "root_cause_description": "Device Design", "action": "A Field Safety Notice dated 10/6/23 was sent to distributors.\n\nWhat do we ask you to do:\n1) Read this field safety notice carefully.\n2) Keep a copy of this notice with the product.\n3) Share this letter with others at your site who need to be made aware of this safety warning and with all other facilities that have received the affected product from your site.\n4) Please keep the content of this message updated until all affected products have been used up.\n\nAvailable support: If you have any questions about this security alert, please contact mo-vis bv, Quality Manager, Rebecca Van Craeymeersch: rebecca.vancraeymeersch@mo-vis.com, phone: +0032-923352860.\n\nAn Urgent Field Corrective Action notification letter was sent to customers on 11/28/23.\n\nmo-vis is committed to bring safe and reliable products into the market and therefore we are initiating a product exchange.\n\nActions taken by mo-vis\nWhat have we done so far?\n- The root cause is identified.\n- Corrective action has been taken to prevent this issue from re-occurring.\n\nWhat is planned?\n- We have asked our distributors to cooperate in a device exchange. Your device will be replaced by a new device, where we have taken corrective actions to prevent this issue. This device exchange will take place over the course of the next six months.\n\nActions required by you\nAll actions described below, only apply to units with serial numbers listed in the FSN!\n1) Until the device is exchanged, you should take into account additional safety information:\n- Do not over-torque the bolt when adjusting the placement of the throttles. Only 1 Nm should be applied. Please use a torque-screwdriver to monitor this. Using a higher torque can evoke the issue.\n- There is a likelihood that a mechanical malfunction will occur. You should be cautious during use and you must be aware that the on/off switch must be used immediately in case of the throttle being stuck.\n- If the device malfunction occurs, the device should not be used anymore and sho", "product_quantity": "129 units", "distribution_pattern": "US States: TN, TX.", "openfda": { "k_number": [ "K913511", "K884052", "K885104", "K923364", "K921369", "K905013", "K885106", "K823875", "K890178", "K942309", "K823877", "K882253", "K913509", "K913546", "K923366", "K913548", "K933051", "K812348", "K885105", "K823876", "K894960", "K870698", "K771631", "K855181", "K915368", "K861755", "K211919", "K942310", "K913549", "K882012", "K840629", "K942311", "K823638", "K904913", "K913545", "K942308", "K913507", "K925980", "K821488", "K861754", "K942260", "K923186", "K921027", "K923942", "K863385", "K913552", "K861751", "K913553", "K900839", "K913550", "K780192", "K862887", "K823874", "K870299", "K854710", "K942312", "K823637", "K894770", "K813636", "K915629", "K925336", "K883679", "K823873", "K820761" ], "registration_number": [ "3007608806", "3009255757", "3010595915", "", "9616873", "3003123807", "3007771912", "3033814356", "3016162044", "3003672078", "3004496806", "8022890", "3005191311", "1417592", "3003636180", "8030931", "3008767869", "3010605307", "3025369303", "3017607477", "3008386507", "9680333", "3004111085", "3025309176", "3009421767", "3009303347", "3008555994", "3013903013", "3023189540", "3008597995", "3006799874", "3008485769", "3009265647", "2085336", "1000109362", "3006534178", "3034669683", "3004526603", "3012316249", "1221084", "1181047", "3032618", "9616091", "3005905321", "3003882673", "3015218514", "2937137", "3032597250", "3008717361", "3030516433", "3004034546", "3009407891", "8022752", "3017171467", "3008630266", "3006703870", "3017526035", "3011475060", "9681725", "3015536186", "3007923118", "3006199389", "3004473024", "3007499787", "9611742", "3008771621", "3033506545", "3008723825", "3031233916", "2135139", "1058069", "3009303364", "3008346606", "3012404688", "3004141004", "9616881", "3008351005", "9618009", "3015925409", "3009560891", "3012521614", "3003820676", "3009041491", "3004730053", "3019984611", "3004905643", "3003681901", "3014982318", "3005037196", "3004594214", "3033433849", "3008388419", "3004727093", "3011795161", "3012781455", "8043717", "3016661582", "3030822491", "1531186", "3003823002", "3009865268", "9613440", "3009596133", "3016913131", "3004945434", "3006774806", "3004577612", "3044470904", "3012411233", "3039359026", "2085249", "3018070833", "3007649424", "8043392", "3009567010", "3011687503", "3014810929", "3011000715", "2531465", "3010394125", "3027643666", "3019677893", "3007728095", "9615350", "9681827", "3007309323", "3007841746", "3008058406", "3021337381", "3044085583", "3005587124", "3006541027", "3007963811", "3038289351", "2081283", "3004452270", "3005660819", "1000292485", "3012958676" ], "fei_number": [ "3007608806", "3009255757", "3010595915", "", "3003123807", "3007771912", "3033814356", "3016162044", "3003672078", "3004496806", "3005191311", "1000221992", "1000253203", "1417592", "3004908349", "3003636180", "3008767869", "3003117095", "3010605307", "3025369303", "3017607477", "3008386507", "3004111085", "3025309176", "3009421767", "3009303347", "3008555994", "3009875802", "3013903013", "3023189540", "3008597995", "3006799874", "3008485769", "3005068474", "3009265647", "1000109362", "3006534178", "3034669683", "3004526603", "3012316249", "1221084", "1181047", "1000413464", "3002329391", "3005905321", "3003882673", "3015218514", "2937137", "3032597250", "3008717361", "3030516433", "3004034546", "3009407891", "3003327839", "3017171467", "3008630266", "3006703870", "3002808508", "3017526035", "3011475060", "3015536186", "3007923118", "3006199389", "3004473024", "3007499787", "1000306460", "3008771621", "3033506545", "3008723825", "3031233916", "3009303364", "3002653226", "3008346606", "3007074101", "3012404688", "3004141004", "3008351005", "3015925409", "3009560891", "3012521614", "3003820676", "3009041491", "3004730053", "3019984611", "3004905643", "3003190528", "3001045529", "3003681901", "3014982318", "3005037196", "3004594214", "3033433849", "3008388419", "3004727093", "3011795161", "3012781455", "3016661582", "3003792251", "3030822491", "3003823002", "3009865268", "3009596133", "3016913131", "3004945434", "3002889431", "3006774806", "3001124347", "3004577612", "3044470904", "3012411233", "3039359026", "3003748905", "3018070833", "3007649424", "3926", "3009567010", "3002847480", "3011687503", "3014810929", "3011000715", "3010394125", "3027643666", "1000334118", "3019677893", "3007728095", "3007309323", "3007841746", "3008058406", "3021337381", "3044085583", "3005587124", "3006541027", "3007963811", "3038289351", "2081283", "3004452270", "3005660819", "1000292485", "3012958676" ], "device_name": "Components, Wheelchair", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3920", "device_class": "1" } } ] }