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U.S. Department of Health and Human Services

Class 1 Device Recall IDMARLITER

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 Class 1 Device Recall IDMARLITERsee related information
Date Initiated by FirmJuly 10, 2025
Date PostedSeptember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2459-2025
Recall Event ID 97354
Product Classification Components, wheelchair - Product Code KNN
ProductIDM-ARLITE-R. Electrical wheelchair component.
Code Information Model No. PRSPS00018. UDI-DI: 05407008320102; Serial No. 1000 to 2647.
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
ActionAn 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 Commerce25 units
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC Device Report

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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