Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1531-2008

Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10

Sunrise Medical, Inc. / initiated 2008-01-11 / Terminated / root cause: software

Sunrise Medical Inc began a recall of Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10 on . The reason FDA records is "Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1531-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10
Product code
ITI Wheelchair, Powered
Reason for recall
Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
Root cause tag
software
FDA root cause
Software design
Action
Initial phone contact began on January 11, 2008. Medical device correction letters were also sent to affected dealers.
Quantity in commerce
141 units total
Distribution
Product was distributed to 126 retailers nationwide throughout the USA, as well as Canada and Australia.
Product codes and lots
All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.