Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2339-2008

Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for...

Sunrise Medical, Inc. / initiated 2006-11-13 / Terminated / root cause: design

Sunrise Medical Inc began a recall of Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use on . The reason FDA records is "Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2339-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use.
Product code
ITI Wheelchair, Powered
Reason for recall
Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
Root cause tag
design
FDA root cause
Device Design
Action
Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.
Quantity in commerce
36 units
Distribution
Worldwide: US, Canada, New Zealand and Australia.
Product codes and lots
Multiple serial numbers, starting with GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100, 099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043, 041, 040, 035, 033, 021 and 013