Events

Recall of Device Recall Solara Spree GT 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
    35772
  • Event Risk Class
    Class 2
  • Event Number
    Z-1510-06
  • Event Initiated Date
    2006-06-27
  • Event Date Posted
    2006-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46844
  • 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 - Product Code IOR
  • Reason
    The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
  • Action
    The recalling firm notified their consignees in a letter dated 6/26/06.

Device

Device Recall Solara Spree GT manual wheelchair.
  • Model / Serial
    06EE011382, 06FE000065, 06FE001632, 06FE001635, 06FE006693, 06FE007246
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Solara Spree GT manual wheelchair.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA