Recall Z-2856-2026— MUNEVO GMBH
Class II · Ongoing
Class II FDA medical device recall by MUNEVO GMBH, initiated 2026-06-19. FDA's recall record names no specific 510(k) clearance for this event. Product: munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System. Reason: 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..
- Recalling firm
- MUNEVO GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-19
- Firm location
- Munich, Germany
Product description
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.