munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelch
Summary
The FDA issued a Class II for munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control App by MUNEVO GMBH. Reason: A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steer.
Details
Source
Device Recall
External ID
Z-2856-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Lot/Code Info: 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
Quantity Affected: 19
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-19
Company
Munich
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MUNEVO GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MUNEVO GMBH have FDA actions?
This is the only FDA action we have on record for MUNEVO GMBH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2856-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29