MUNEVO GMBH
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
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
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →