Zippie IRISRecalls & reported problems
Sunrise Medical (US) LLC · The Zippie IRIS® rotation-in-space wheelchair offers a superior combination of positioning, maneuverability, and increased portability with the XLOCK® folding crossbrace option. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00016958048957), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Misassembly by Users” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Misassembly by Users1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2021Misassembly by Users; Misassembly by Users
CAREGIVER REPORTED THAT THE END USER WAS BEING PUSHED IN HIS MANUAL WHEELCHAIR AT SCHOOL WHEN THE WHEEL CAME OFF. CAREGIVER REPORTED A FALL WITH "QUITE NASTY CUTS AND BRUISES, BUT THANKFULLY NO BROKEN BONES OR CONCUSSION." MEDICAL ATTENTION WAS NOT REPORTED.
Patient problems: Fall
MAUDE report 12586812 ↗
Other Wheelchair, Mechanical devices
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- MEDLINE INDUSTRIES, INC. MDS808650Medline Industries, Inc. · Wheelchair, mechanical18 reports
- Medline MDS806850Medline Industries, Inc. · Wheelchair, mechanical17 reports
- Guardian K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- MEDLINE K3186N34SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.