FDA (Devices) recall action 71829
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
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.
Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.
Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.