FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+
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
Related Articles
-
As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations mean for laboratories developing and selling LDTs.
-
Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements.
-
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would represent roughly 10% of the program’s total staffing.
-
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
