Food, drugs, devices › Sunrise Medical (US) LLC
Device recall: Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie
FDA enforcement event 62493 is a device recall by Sunrise Medical (US) LLC of Fresno, CA, initiated 26 Jun 2012 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 1 Nov 2012. Initiation: voluntary: firm initiated. Sunrise Medical (US) LLC has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sunrise Medical (US) LLC, Fresno, CA.
Reason for recall
"Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm."
Distribution
"Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2113-2012 | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions. | 14, 035 | Class II | Terminated | 8 Aug 2012 |
Context
Other enforcement events for Sunrise Medical (US) LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Jul 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assistin | Device | Class II | 2 |
| 13 Feb 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power | Device | Class II | 1 |
| 1 Jul 2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mo | Device | Class II | 1 |
| 27 Jul 2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest | Device | Class II | 2 |
| 19 Dec 2014 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | Device | Class II | 2 |
| 11 Nov 2013 | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufact | Device | Class II | 1 |
All 7 events for Sunrise Medical (US) LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Nov 2012. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.