FDA (Devices) recall action 97354
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
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.
IDM-MULTI-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.
Multi Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
All-round Joystick R-net Light wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
Micro Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
IDM-ARLITE-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 25 units are affected.
IDM-MICRO-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.