Events

Recall of Solara 3G Custom Manual Wheelchair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64044
  • Event Risk Class
    Class 2
  • Event Number
    Z-0785-2013
  • Event Initiated Date
    2012-09-10
  • Event Date Posted
    2013-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115268
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, mechanical - Product Code IOR
  • Reason
    The potential exists for the wheel to rotate freely despite engagement of hub brake.
  • 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.

Device

Solara 3G Custom Manual Wheelchair
  • Model / Serial
    Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of CA & MT.
  • Product Description
    Solara 3G Custom Manual Wheelchair || Product Usage: To provide mobility to a person restricted to a sitting position.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA