Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1103-2012

Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility

Sunrise Medical, Inc. / initiated 2012-01-13 / Terminated / root cause: manufacturing process

Sunrise Medical (US) LLC began a recall of Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility on . The reason FDA records is "One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1103-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility.
Product code
IOR Wheelchair, Mechanical
Reason for recall
One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
Sunrise Medical contacted customer by telephone on January 17, 2012 to arrange for removal of transit brackets. The Sunrise Sales rep then visited the customers on January 18, 2012 and removed the bracket from the chair making it appropriate for intended use. If you need any additional information or have any questions, call 559-348-2572 or email: [email protected].
Quantity in commerce
1 chair
Distribution
Nationwide distribution: OK only.
Product codes and lots
Model number: E1Z1A; Serial number: Z1SE-006474.