Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-

FDA device recall Z-0579-2010 · posted 2009-12-29 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

ITI

Quantity affected

36

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.

Date initiated

2009-09-15

Date posted

2009-12-29

Date terminated

2014-08-25

Location

Elyria, OH

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