Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2012-06-12 | Z-2695-2014 | Class II | Terminated | The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.Distribution: Worldwide Distribution- US Distribution including the states of : AZ, CA, GA, KY, MI, MN, MO, MS, NC, NE, NY, OH, PA, SC, TX, VA, and WA., and Internationally to Canada and Hong Kong. | 153 | clearance family |
Regulatory clearances
Manufacturer compliance record
None in the loaded window.
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