Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel
Summary
The FDA issued a Class I for Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in co by Max Mobility LLC. Reason: Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of de.
Details
Source
Device Recall
External ID
Z-1116-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
Product Description
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Lot/Code Info: All serial numbers manufactured between August 17,2023 through November 21, 2024
Quantity Affected: unknown
Reason for Recall
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-20
Company
Lebanon, TN
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 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Max Mobility LLC has 5 FDA actions in our database, including 5 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 (Max Mobility LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Max Mobility LLC have FDA actions?
Max Mobility LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1116-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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