Summary
The FDA issued a Class I for IDM-MULTI-R. Electrical wheelchair component. by mo-Vis BVBA. Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neu.
Details
Source
Device Recall
External ID
Z-2457-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
IDM-MULTI-R. Electrical wheelchair component.
Lot/Code Info: Model No. PRSPS0016; UDI-DI: 05407008320850; Serial No. 1000 to 1690.
Quantity Affected: 15 units
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.
Distribution
US Nationwide distribution in the state of TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-10
Company
Nevele, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
mo-Vis BVBA has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (mo-Vis BVBA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does mo-Vis BVBA have FDA actions?
mo-Vis BVBA has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2457-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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