munevo DRIVE wheelchair software recalled for potential steering drift
munevo GmbH is recalling munevo DRIVE and munevo DRIVE r-net powered wheelchair control systems because a software issue may cause the driving mechanism to fall out of calibration. This may cause unexpected steering drift or imprecise control, and the wheelchair may veer from its intended path, possibly causing a low-speed collision, tipping, or injuries to the user or bystanders. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether your munevo DRIVE software is version 10.14.5 to 12.0.4, or your munevo DRIVE r-net software is version 10.17.5 to 12.0.4.
- Compare your device's serial number with the list of 19 affected units in the notice (UDI-DI 04260691380010).
- The notice doesn't say how to get a remedy; contact munevo GmbH for instructions on affected units.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 19
- Illnesses reported
- None reported
- Manufactured in
- Agnes-Pockels-Bogen 1, Munich, Germany
- Classification
- Class II
- Recall number
- Z-2856-2026
In the FDA's words
- Description
- munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System 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. 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 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. Affected quantity: 19
- 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.