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Recall Observatory FDA recall evidence

Device product

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Z-1116-2025

December 20, 2024

Class I

Product summary

Firm
Max Mobility LLC
Event
Event 96086
Status
Ongoing
Classification
Class I
Quantity
unknown
Official record key
device-enforcement:Z-1116-2025

Official wording

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 device potentially resulting in minor and major injuries.

Code information: All serial numbers manufactured between August 17,2023 through November 21, 2024

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.