munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
MUNEVO GMBH
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 2QNTGG2820170047Model 2QNTGG2820160730Model 2QNTGG2820161031Model 1QNTGG2519120215Model 1QNTGG2818520491Model 1QNTGG2819210671Model 2QNTGG2820160358Model 2QNTGG2820170527Model 2QNTGG2820160265Model 2QNTGG2820160732Model 1QNTGG2819200073Model 2QNTGG2820160746Model 2QNTGG2820160410Model 2QNTGG2820160500Model 2QNTGG2820160368Model 2QNTGG2820161091Model 2QNTGG2820161026Model 2QNTGG2820160699UPC 04260691380010Would you have heard about this one?
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