Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controll
Summary
The FDA issued a Class II for Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to su by mo-Vis BVBA. 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 .
Details
Source
Device Recall
External ID
Z-0713-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 05407008320119; Lot Numbers: 3304-3317 3322-3329 3440-3452 3569-3618 3830-3844 4020-4054 4170-4176 4250-4255 4321-4330
Quantity Affected: 129 units
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.
Distribution
US States: TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Nevele
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
mo-Vis BVBA has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (mo-Vis BVBA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does mo-Vis BVBA have FDA actions?
mo-Vis BVBA has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0713-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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