Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2459-2025Class I

IDM-ARLITE-R. Electrical wheelchair component

MO-Vis BV / initiated 2025-07-10 / Open, Classified / root cause: design

mo-Vis BVBA began a recall of IDM-ARLITE-R. Electrical wheelchair component on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-2459-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
MO-Vis BV
Product
IDM-ARLITE-R. Electrical wheelchair component.
Product code
KNN Components, Wheelchair
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.
Root cause tag
design
FDA root cause
Device Design
Action
An URGENT: MEDICAL DEVICE RECALL R-NET JOYSTICKS notification dated 07/10/2025 was sent to consignees instructing them to upgrade affected devices according to the provided Annex 2 or by emailing [email protected] to coordinate return. The software upgrade of affected devices should be conducted during the next scheduled annual maintenance of the joystick. These actions should be verified. Questions can be directed via email to [email protected] or by phone at +32 9 335 28 60.
Quantity in commerce
25 units
Distribution
US Nationwide distribution in the state of TX.
Product codes and lots
Model No. PRSPS00018. UDI-DI: 05407008320102; Serial No. 1000 to 2647.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2459-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2454-2025Class IOngoingVoluntary: Firm initiated
Z-2455-2025Class IOngoingVoluntary: Firm initiated
Z-2456-2025Class IOngoingVoluntary: Firm initiated
Z-2457-2025Class IOngoingVoluntary: Firm initiated
Z-2458-2025Class IOngoingVoluntary: Firm initiated
Z-2459-2025Class IOngoingVoluntary: Firm initiated