FDA Device Recall Z-2454-2025

mo-Vis BVBA · Nevele, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Micro Joystick R-net. Electrical wheelchair component.

Lot / serial / GTIN: Model No. P002-52; UDI-DI: 05407008320027; Serial No. 1000 to 1690.

Quantity: 3 units

Reason for recall

Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.

Recall record

Recall number: Z-2454-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide distribution in the state of TX.
Recall initiated: 2025-07-10
Classified by FDA Center: 2025-09-02
FDA published: 2025-09-10
Recalling firm: mo-Vis BVBA
Firm location: Nevele, N/A, Belgium

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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