FDA recall record

mo-Vis BVBA Scoot Control R-net, Product Number P015-61 recall — FDA Z-0713-2024

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…

Class IIclassification
Z-0713-2024official record ID
Jan 17, 2024report date

Recall record at a glance

Official recordZ-0713-2024
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmmo-Vis BVBA
Report dateJan 17, 2024
Recall initiation dateNov 28, 2023
Quantity129 units
LocationNevele, Belgium

Official 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

Why the product was recalled

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.

Distribution information

US States: TN, TX.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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