Retiro De Equipo (Recall) de Solara 3G Custom Manual Wheelchair

Recall

64044

Class 2

Z-0785-2013

2012-09-10

2013-02-04

Terminated

United States

2014-05-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115268

The potential exists for the wheel to rotate freely despite engagement of hub brake.

Invacare sent an URGENT: RECALL INFORMATION Letter dated September 10, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1) Complete the Provider Response Card indicating your receipt and understanding of these instructions. 2) Contact your customers to inform them of the recall. It is recommended that you provide them with the enclosed Customer Letter. Set up an appointment to correct the customer's wheelchair as soon as possible. 3) Please examine the wheelchair to confirm it has one of the serial numbers listed above. The serial number can be found on the front lower crossbar located on the right while sitting in the chair. 4) Using the enclosed retrofit kit, make the necessary correction. Installation instructions can be found on page 109 of the Solara service manual, which is enclosed. 5) Document the correction of the wheelchair on the enclosed tracking sheet. 6) Using the enclosed pre-paid UPS mailing label and original box, return the replaced parts to the address listed on the label. 7) Fax or email the Provider Response Form and tracking sheet to 330-329-3458 or recall@invacare.com. For questions please contact Invacare Customer Service at 800-333-6900.