TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, T

FDA device recall Z-1905-2012 · posted 2012-06-29 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.

Action taken

Invacare sent an "URGENT: RECALL INFORMATION" letter dated June 7, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. THe letters instructs customers to examine their inventory for the affected product and quarantine any product found. AProvider Response Form was enclosed for customers to complete and return via fax to 888-345-0289. Contact the firm at 888-641-9738 for assistance with this recall.

Root cause

Employee error

Status

Terminated

Product code

ITI

Quantity affected

665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified.

Distribution

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR,

Date initiated

2012-04-06

Date posted

2012-06-29

Date terminated

2014-05-20

Location

Elyria, OH

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