Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727

FDA Recall Z-0518-06 · Posted 2006-02-14

Recalling FirmSunrise Medical Inc
Recall StatusTerminated
Product CodeITI
Date Initiated2005-11-15
Date Terminated2006-12-28
Product Quantity5 units

Reason for Recall

While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.

Firm Action

On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.

Root Cause

Other

Distribution Pattern

All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031289QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424Sunrise Medical, Inc. · 2003-05-09

Official Source

View FDA Recall →

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

↑