Events

Recall of Invacare Storm TDX SR Power Wheelchair with Stability Lock

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
    53871
  • Event Risk Class
    Class 2
  • Event Number
    Z-0579-2010
  • Event Initiated Date
    2009-09-15
  • Event Date Posted
    2009-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86767
  • 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
    Powered wheelchair - Product Code ITI
  • Reason
    For some invacare chairs, the stability lock feature may not be engaging properly or consistently. if the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. in these cases there is a risk to injury for.
  • Action
    On 9/15/2009 the firm sent recall notification letter to their customers instructing them to immediately contact the dealer to have the stability lock inspected and/or adjusted. If the dealer is unavailable or the repair will take longer than 60 days, they are to contact the firm and arrange for an inspection and/or adjustment. Invacare requested contact names to whom it can send additional information. Invacare plans to mail, via FEDEX, information regarding the recall to each consignee. Initial consignees received a response card and instructions to forward cards to any customer to whom they have distributed the product. The products are to be inspected at the cylinder label and if the label does not have a long alpha-numeric string demonstrated in the label, the cylinders on the chair have to be replaced. Questions are directed to Recalls@Invacare.com or to 800-333-6900.

Device

Invacare Storm TDX SR Power Wheelchair with Stability Lock
  • Model / Serial
    Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.
  • Product Description
    Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA