Recall Z-0713-2024— mo-Vis BVBA

Class II · Ongoing

Class II FDA medical device recall by mo-Vis BVBA, initiated 2023-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair. Reason: In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers..

Recalling firm
mo-Vis BVBA
Classification
Class II
Status
Ongoing
Initiated
2023-11-28
Firm location
Nevele, Belgium

Product description

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

Reason for recall

In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.

Data sourced from openFDA. This site is unofficial and independent of the FDA.