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U.S. Department of Health and Human Services

Class 2 Device Recall munevo DRIVE

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 Class 2 Device Recall munevo DRIVEsee related information
Date Initiated by FirmJune 19, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2856-2026
Recall Event ID 99328
Product Classification Components, wheelchair - Product Code KNN
Productmunevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Code Information 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
FEI Number 3021337381
Recalling Firm/
Manufacturer		 MUNEVO GMBH
Agnes-Pockels-Bogen 1
Munich Germany
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionOn 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. The firm has developed software patch Version 12.1.7 (v1), and 12.2.6 (R-net) (released patch on June 17 2026) which corrects the profile retention database loop, ensuring the device consistently locks onto the last saved user profile during boot. This software patch was released to all users on June 17, 2026. Customers 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.)
Quantity in Commerce19
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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