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munevo DRIVE and munevo DRIVE r-net recallZ-2856-2026 · Munevo GMBH · initiated Jun 19, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Munevo GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software Design Change

What the company is doing

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.)

Recall details

Recall number
Z-2856-2026
Status
Open, Classified
Initiated by the company
Jun 19, 2026
Posted by the FDA
Jul 31, 2026
Recalling firm
Munevo GMBH
Quantity
19
Product code
KNN
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 description

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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