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Scoot Control R-net, Product Number P015-61. The Scoot… recallZ-0713-2024 · mo-Vis BVBA · initiated Nov 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from mo-Vis BVBA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it 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.

FDA root cause category: Device Design

What the company is doing

A Field Safety Notice dated 10/6/23 was sent to distributors. What do we ask you to do: 1) Read this field safety notice carefully. 2) Keep a copy of this notice with the product. 3) Share this letter with others at your site who need to be made aware of this safety warning and with all other facilities that have received the affected product from your site. 4) Please keep the content of this message updated until all affected products have been used up. Available support: If you have any questions about this security alert, please contact mo-vis bv, Quality Manager, Rebecca Van Craeymeersch: [email protected], phone: +0032-923352860. An Urgent Field Corrective Action notification letter was sent to customers on 11/28/23. mo-vis is committed to bring safe and reliable products into the market and therefore we are initiating a product exchange. Actions taken by mo-vis What have we done so far? - The root cause is identified. - Corrective action has been taken to prevent this issue from re-occurring. What is planned? - We have asked our distributors to cooperate in a device exchange. Your device will be replaced by a new device, where we have taken corrective actions to prevent this issue. This device exchange will take place over the course of the next six months. Actions required by you All actions described below, only apply to units with serial numbers listed in the FSN! 1) Until the device is exchanged, you should take into account additional safety information: - Do not over-torque the bolt when adjusting the placement of the throttles. Only 1 Nm should be applied. Please use a torque-screwdriver to monitor this. Using a higher torque can evoke the issue. - There is a likelihood that a mechanical malfunction will occur. You should be cautious during use and you must be aware that the on/off switch must be used immediately in case of the throttle being stuck. - If the device malfunction occurs, the device should not be used anymore and sho

Recall details

Recall number
Z-0713-2024
Status
Open, Classified
Initiated by the company
Nov 28, 2023
Posted by the FDA
Jan 11, 2024
Recalling firm
mo-Vis BVBA
Quantity
129 units
Product code
KNN
Distribution
US States: TN, TX.

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page