Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0518-06

Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by...

Sunrise Medical, Inc. / initiated 2005-11-15 / Terminated

Sunrise Medical Inc began a recall of Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno... on . The reason FDA records is "While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0518-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
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
Product code
ITI Wheelchair, Powered
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.
FDA root cause
Other
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.
Quantity in commerce
5 units
Distribution
All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.
Product codes and lots
Serial numbers: 1GMo1B5500522 1GL02B7500022, 1GL02B7500019, 1GM01B6500422, 1GL02B9400338