Recall Z-2856-2026
Munevo GmbH · initiated June 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Codes / lots: 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
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: Software Design Change
Action taken
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. 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.)
Details
- Recall number
- Z-2856-2026
- Initiated
- June 19, 2026
- Posted by FDA
- July 31, 2026
- Product code
- KNN – Components, Wheelchair
- Quantity
- 19
- Distribution
- 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.
- Recalling firm
- Munevo GmbH, Munich