{"recall":{"id":"fda-device-99328","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"MUNEVO GMBH recalls munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/","firm":"MUNEVO GMBH","date":"2026-06-19","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System","code":"Affected software versions: munevo DRIVE v1: 10.14.5 - 12.0.4; munevo DRIVE R-net: 10.17.5. - 12.0.4 UDI-DI 04260691380010 Units with affected features enabled: 2QNTGG2820170029, 2QNTGG2820170047, 2QNTGG2820160730, 2QNTGG2820161031, 1QNTGG2519120215, 1QNTGG2818520491, 1QNTGG2819210671, 2QNTGG2820160358, 2QNTGG2820170527, 2QNTGG2820160265, 2QNTGG2820160732, 1QNTGG2819200073, 2QNTGG2820160746, 2QNTGG2820160410, 2QNTGG2820160500, 2QNTGG2820160368, 2QNTGG2820161091, 2QNTGG2820161026, 2QNTGG2820160699","quantity":"19","number":"Z-2856-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"19","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99328","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c35b8da1e63b0b28","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99328","record":[{"status":"Ongoing","city":"Munich","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99328","recalling_firm":"MUNEVO GMBH","address_1":"Agnes-Pockels-Bogen 1","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2856-2026","product_description":"munevo DRIVE and munevo DRIVE r-net    Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System","product_quantity":"19","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.","recall_initiation_date":"20260619","center_classification_date":"20260731","report_date":"20260812","code_info":"Affected software versions: munevo DRIVE v1: 10.14.5 - 12.0.4; munevo DRIVE R-net: 10.17.5. - 12.0.4 UDI-DI 04260691380010  Units with affected features enabled: 2QNTGG2820170029, 2QNTGG2820170047, 2QNTGG2820160730, 2QNTGG2820161031, 1QNTGG2519120215, 1QNTGG2818520491, 1QNTGG2819210671, 2QNTGG2820160358, 2QNTGG2820170527, 2QNTGG2820160265, 2QNTGG2820160732, 1QNTGG2819200073, 2QNTGG2820160746, 2QNTGG2820160410, 2QNTGG2820160500, 2QNTGG2820160368, 2QNTGG2820161091, 2QNTGG2820161026, 2QNTGG2820160699","more_code_info":""}]}}