Z-2113-2012Class II

Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4)...

Name: Z-2113-2012 Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4)...
Creator: Sunrise Medical (US) LLC
Published: 2012-06-26
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2012-06-26 / Terminated / root cause: labeling and UDI

FDA source

Sunrise Medical (US) LLC began a recall of 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... on 2012-06-26. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2113-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-26
Posted: 2012-07-31
Terminated: 2012-11-01
Recalling firm: Sunrise Medical, Inc.
Product: 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.
Product code: IOR Wheelchair, Mechanical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.
Quantity in commerce: 14, 035
Distribution: Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
Product codes and lots: Receiver Product number 109207.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2113-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2113-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-31

Product code IOR

K973673Class IQuickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid SeriesSunrise Medical, Inc. / cleared 1997-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)