FDA Medical Device Recalls (openFDA)
MUNEVO GMBH: munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
- Recall number
- Z-2856-2026
- Recalling firm
- MUNEVO GMBH
- Product
- munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
- Status
- Open, Classified
- Initiated
- 2026-06-19
- Posted
- 2026-07-31
- Terminated
- not on file
- 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.
- Root cause
- 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. 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNN
- Firm FEI
- 3021337381
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28