FDA (Devices) recall action 97356
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.
SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCMC, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 8,413 units are affected.
SmartDrive MX2+ SpeedControl Dials are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. The FDA classified the action as Class I. 25,389 units are affected.