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Recall Observatory FDA recall evidence

Device 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.

Z-2113-2012

June 26, 2012

Class II

Product summary

Firm
Sunrise Medical (US) LLC
Event
Event 62493
Status
Terminated
Classification
Class II
Quantity
14, 035
Official record key
device-enforcement:Z-2113-2012

Official wording

Reason: 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.

Code information: Receiver Product number 109207.

Distribution pattern: Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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