Z-2856-2026Class II

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses...

Name: Z-2856-2026 munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses...
Creator: Munevo Gmbh
Published: 2026-06-19
License: https://open.fda.gov/license/

Munevo GmbH / initiated 2026-06-19 / Open, Classified / root cause: software

FDA source

MUNEVO GMBH began a recall of munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System on 2026-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2856-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-19
Posted: 2026-07-31
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
Product code: KNN Components, Wheelchair
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2856-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2856-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code KNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)