United StatesMunevo GMBH’s munevo DRIVE and munevo DRIVE r‑net powered wheelchair hands‑free control system (smart glasses interface/head control) running software versions munevo DRIVE v1 10.14.5–12.0.4 or munevo DRIVE R‑net 10.17.5–12.0.4, UDI‑DI 04260691380010, is included in a recall affecting 19 units distributed worldwide (including the U.S. states of California, Florida, North Carolina, Texas, Utah, and Washington, and the UK, Spain, Italy, Germany, and Switzerland). A software issue may cause the driving mechanism to fall out of calibration, resulting in unexpected steering drift or imprecise control that can make the wheelchair veer from its intended path and potentially cause low‑speed collisions, tipping, or injuries to users or bystanders.
What's being recalled
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Recalling firm: Munevo GMBH, Munich, Germany.
How to identify it
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
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)