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Recall Observatory FDA recall evidence

Device 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

Z-0713-2024

November 28, 2023

Class II

Product summary

Firm
mo-Vis BVBA
Event
Event 93556
Status
Ongoing
Classification
Class II
Quantity
129 units
Official record key
device-enforcement:Z-0713-2024

Official wording

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.

Code information: UDI-DI: 05407008320119; Lot Numbers: 3304-3317 3322-3329 3440-3452 3569-3618 3830-3844 4020-4054 4170-4176 4250-4255 4321-4330

Distribution pattern: US States: TN, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.