Sunita Somvanshi
A nationwide recall of the SmartDrive MX2+ Power Assist Device’s Speed Control Dial component has been initiated by Max Mobility/Permobil due to serious safety concerns. The recall affects units manufactured between August 17, 2023, and November 21, 2024.
The issue stems from a material change in the printed circuit board assembly, leading to potentially dangerous malfunctions. As of December 12, 2024, 646 complaints have been reported, including three serious injuries – a fractured hip, fractured tibia, and fractured malleolus bone.
The device’s failures manifest in four critical ways: continued motor operation despite zero-position settings, unexpected movement activation during standby mode, sudden power loss during operation, and failure to activate when commanded. These malfunctions pose significant risks to both users and nearby individuals.
“We are voluntarily issuing this Urgent Medical Device Recall,” states Audra Watt, VP Marketing at Permobil Americas. The FDA has been notified and posted the announcement on January 17, 2025.
The safety implications extend beyond the immediate user. People standing or sitting near the wheelchair user could suffer serious injuries, including bone fractures, if the device activates unexpectedly or fails to deactivate. Other potential injuries range from minor skin irritations and bruises to more severe muscle strains and concussions.
Max Mobility/Permobil has established a comprehensive replacement process. Users and dealers must access the company’s field action portal through https://hub.permobil.com/smartdrive-scd-voluntary-field-action to request replacement units. Technical support is available Monday through Friday, 8:00 am to 5:00 pm CT at (800) 736-0925.
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For power assist device users, this recall highlights the importance of responding promptly to safety notifications. These devices play a crucial role in daily mobility, making quick resolution of safety issues essential for users’ wellbeing.
Affected users can report adverse events or quality problems to the FDA’s MedWatch Adverse Event Reporting program, either online or through regular mail and fax services. This systematic reporting helps maintain safety standards in medical mobility devices and prevents similar issues in future developments.
The recall demonstrates the importance of quality control in medical mobility devices, where equipment reliability directly affects users’ daily safety and independence. This incident reinforces the need for careful attention to safety in medical device manufacturing.
