Powered Wheelchair Control Software Recall by munevo
Munevo is recalling 19 powered wheelchair hands-free control systems due to a software issue that may cause the driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device (powered wheelchair control system) where the software malfunction could lead to steering drift, collisions, tipping, or injuries to users or bystanders, meeting the rubric criterion for significant injury reports.
Plain-English summary
Munevo GMBH is recalling 19 units of the munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System. The recall affects specific software versions: munevo DRIVE v1 versions 10.14.5 through 12.0.4, and munevo DRIVE R-net versions 10.17.5 through 12.0.4, with affected unit identifiers listed in the recall notice.
The recalled devices have a software issue that 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 low-speed collisions, tipping, or injuries to the user or bystanders.
The affected units were distributed nationwide in the United States (California, Florida, North Carolina, Texas, Utah, and Washington) and internationally in the United Kingdom, Spain, Italy, Germany, and Switzerland.
Consumers using these devices should contact Munevo to update the software to a corrected version. Users should also be aware of the potential for steering drift or imprecise control and exercise caution until the software update is applied.
The recalled product
- Product
- munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
- Manufacturer
- MUNEVO GMBH
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Affected software versions: munevo DRIVE v1: 10.14.5 - 12.0.4
- 2QNTGG2820170047
- 2QNTGG2820160730
- 2QNTGG2820161031
- 1QNTGG2519120215
- 1QNTGG2818520491
- 1QNTGG2819210671
- 2QNTGG2820160358
- 2QNTGG2820170527
- 2QNTGG2820160265
- 2QNTGG2820160732
- 1QNTGG2819200073
- 2QNTGG2820160746
- 2QNTGG2820160410
- 2QNTGG2820160500
- 2QNTGG2820160368
- 2QNTGG2820161091
- 2QNTGG2820161026
- 2QNTGG2820160699
Distribution
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