Mo-Vis BVBA has announced an urgent firmware correction for their R-net joystick devices used in powered wheelchairs. This update responds to a critical safety issue identified in firmware versions 2.3 and lower, which could lead to unexpected wheelchair movement. Clinical, quality, and regulatory teams should pay close attention to the potential risks and recommended actions outlined below.
What changed?
The recall targets R-net joystick models equipped with outdated firmware (version 2.3 and lower). The manufacturer’s firmware update (version 2.6) addresses an error where the joystick fails to recognize its neutral position, resulting in unintended movement of the wheelchair. Mo-Vis BVBA has issued guidance for performing software updates, including step-by-step instructions to ensure the correction is completed successfully.
Who is affected?
This recall impacts all users of mo-Vis R-net proportional joystick products in the United States and globally. Specific affected models include:
- Micro Joystick R-net
- Multi Joystick R-net
- IDM-MICRO-R
- IDM-MULTI-R
- All-round Joystick R-net Light
- IDM-ARLITE-R
Customers utilizing these devices should verify the firmware version and prioritize performing the upgrade during the product’s next scheduled annual maintenance.
What are the risks?
According to the FDA, the joystick malfunction may lead to severe injuries or fatalities. Documented risks include:
- Chronic pain stemming from accidents
- Loss of mobility and reduced functional independence
- Post-concussive syndromes
- Infections requiring surgical intervention
- Extended hospitalizations
To date, one injury has been reported without any fatalities.
What is the device used for?
Mo-Vis R-net joysticks are proportional joysticks designed for powered wheelchair users requiring alternative drive controls. The joystick integrates into the wheelchair’s control box, allowing users to operate mobility functions.
What should customers do?
Mo-Vis BVBA recommends the following:
- Perform a firmware update to version 2.6 during the next scheduled maintenance.
- Follow manufacturer-provided instructions to complete this update.
- Verify the correction post-update by ensuring the firmware version reads 2.6.
- If issues arise during the update process, contact mo-Vis BVBA directly for support via phone or email.
For firmware update assistance, email contact@mo-vis.com or call +32-9-335-28-60.
Unique Device Identifier (UDI)
The UDI system enables traceability of medical devices from manufacture to patient use. It supports effective reporting and analysis of adverse events, ensuring quicker corrective actions when needed.
How can I report a problem?
Patients and healthcare professionals are encouraged to report incidents or quality concerns involving R-net joysticks through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Conclusion
Mo-Vis BVBA’s firmware correction for R-net joysticks addresses a critical safety error. Healthcare providers and users should act promptly to mitigate risks by performing the recommended software upgrade. Monitoring for further FDA updates is advised.
Disclaimer
This content is intended for informational purposes only and does not constitute legal advice or a replacement for official agency communication.