Class 2 Device Recall Scoot Control Rnet

• Date Initiated by Firm: November 28, 2023
• Date Posted: January 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0713-2024
• Recall Event ID: 93556
• Product Classification: Components, wheelchair - Product Code KNN
• 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
• 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
• Recalling Firm/ Manufacturer: mo-Vis BVBA; Biebuyckstraat 15D; Nevele Belgium
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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: rebecca.vancraeymeersch@mo-vis.com, 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
• Quantity in Commerce: 129 units
• Distribution: US States: TN, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.