FDA recall Z-2540-2025

Max Mobility LLC · Class I · device

Product

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

Reason for recall

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or 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: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKG

Key facts

Status
Ongoing
Initiation date
2025-08-12
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lebanon, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2025