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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2454-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2455-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2456-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2457-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2458-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2459-2025 | Class I | Ongoing | Voluntary: Firm initiated |
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