Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1905-2012Class II

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

Invacare GmbH / initiated 2012-04-06 / Terminated / root cause: manufacturing process

Invacare Corporation began a recall of TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1905-2012
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.
Product code
ITI Wheelchair, Powered
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.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
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.
Quantity in commerce
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, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.
Product codes and lots
TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, and FDX-MCG.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1905-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1905-2012Class IITerminatedVoluntary: Firm initiated