Max Mobility, a part of Permobil, has broadened its recall of the Speed Control Dial for the SmartDrive MX2+ Power Assist Device. The recall addresses a potential safety issue where a material change in the printed circuit board assembly can lead to performance malfunctions. This issue might cause unintended activation of the power assist or loss of control over the SmartDrive motor. The recall initially began on December 20, 2024.
Affected Speed Control Dials were manufactured and shipped between August 17, 2023, and March 10, 2025. "Products may have been inadvertently comingled with redesigned products and shipped after December 20, 2024," according to the company. All customers affected by this recall extension will be directly notified by the company with further instructions.
Max Mobility/Permobil has reported 781 complaints related to this issue, with five serious injuries, including broken bones and concussions, attributed to the Speed Control Dial malfunction as of March 27, 2025.
Users are advised to stop using the Speed Control Dial immediately. Alternate controllers, such as Switch Control buttons or compatible smartwatches, are recommended. Replacement instructions and further actions can be accessed through the company's field action portal.
Adverse effects or potential quality issues with the device can be reported online or via mail or fax, as detailed by the FDA's MedWatch program.
Audra Watt, VP of Marketing at Permobil Americas, emphasized, “We are voluntarily issuing this Urgent Medical Device Recall and the U.S. Food and Drug Administration has been notified of this action.”
Permobil's technical support can be contacted for assistance, available weekdays, from 8:00 am to 5:00 pm CT.
