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Terminated

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

FDA Recall Z-2339-2008 · Posted 2008-09-23

Recalling FirmSunrise Medical Inc
Recall StatusTerminated
Product CodeITI
Date Initiated2006-11-13
Date Terminated2009-12-22
Product Quantity36 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide: US, Canada, New Zealand and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060531QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLSSunrise Medical · 2006-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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