| Date Initiated by Firm | July 10, 2025 |
| Date Posted | September 02, 2025 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2456-2025 |
| Recall Event ID |
97354 |
| Product Classification |
Components, wheelchair - Product Code KNN
|
| Product | IDM-MICRO-R. Electrical wheelchair component. |
| Code Information |
Model No. PRSPS0014; UDI-DI: 05407008320836; Serial No. 1000 to 1690. |
Recalling Firm/ Manufacturer |
mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium
|
Manufacturer 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. |
FDA Determined Cause 2 | 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 contact@mo-vis.com 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 contact@mo-vis.com or by phone at +32 9 335 28 60. |
| Quantity in Commerce | 15 units |
| Distribution | US Nationwide distribution in the state of TX. |
| Total Product Life Cycle | TPLC Device Report |
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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.
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