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U.S. Department of Health and Human Services

Class 2 Device Recall Solara 3G Custom Manual Wheelchair

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 Class 2 Recall
Solara 3G Custom Manual Wheelchair
see related information
Date Posted February 04, 2013
Recall Status1 Open
Recall Number Z-0785-2013
Recall Event ID 64044
Premarket Notification
510(K) Number
K984447 
Product Classification Wheelchair, Mechanical - Product Code IOR
Product Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Code Information Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.
Recalling Firm/
Manufacturer
Invacare Corporation
1 Invacare Way
Elyria, Ohio 44035-4190
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The potential exists for the wheel to rotate freely despite engagement of hub brake.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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.
Quantity in Commerce 3 units
Distribution US Nationwide Distribution including the states of CA & MT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = INVACARE CORP.
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