FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+
Speed control circuit board issue that may cause the motor to be unresponsive to the user. The post FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ appeared first on MedTech Intelligence.
FDA RECALL NOTIFICATION
Max Mobility/Permobil is recalling the SpeedControl Dial component used with the SmartDrive MX2+ Power Assist Device due to a circuit board issue that may cause the motor to be unresponsive to the user. Specifically, the device may continue to drive, move on its own without user input, lose power, or fail to start driving.
The use of affected product may cause serious adverse health consequences for users and bystanders, including skin irritation, minor cuts, bruises, muscle or ligament strain or tear, bone fractures, concussion, and death.
There have been 13 reported injuries, and the FDA has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it…READ MORE
The post FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ appeared first on MedTech Intelligence.
