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U.S. Department of Health and Human Services

Class 2 Device Recall TDX SP Power Wheelchair

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  Class 2 Device Recall TDX SP Power Wheelchair see related information
Date Initiated by Firm February 10, 2012
Date Posted March 12, 2012
Recall Status1 Terminated 3 on August 25, 2014
Recall Number Z-1201-2012
Recall Event ID 61160
510(K)Number K023589  
Product Classification Wheelchair, powered - Product Code ITI
Product TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By:
Invacare Corporation, Elyria, OH 44035

The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.
Code Information Model# TDXDP-CG, Serial# 11HE001056; Model# TDXP-CG, Serial# 11GE004364, 11HE000039; Model# TDXSP-CG, Serial# 11GE001580, 11GE001593, 11GE001874, 11GE001886, 11GE001919, 11GE001919, 11GE001920, 11GE002363, 11GE002455, 11GE002456, 11GE002464, 11GE002622, 11GE002625, 11GE002635, 11GE002839, 11GE002850, 11GE003048, 11GE003075, 11GE003249, 11GE003258, 11GE003500, 11GE003503, 11GE003687, 11GE003690, 11GE003931, 11GE003934, 11GE004230, 11GE004354, 11GE004355, 11GE004356, 11GE004359, 11GE004361, 11GE004490, 11GE004638, 11GE004642, 11HE000047, 11HE000333, 11HE000335, 11HE000343, 11HE000344, 11HE000508, 11HE000748, 11HE000749, 11HE000752, 11HE000755, 11HE000848, 11HE001057, 11HE001243, 11HE001244, 11HE001246, 11HE001311, 11HE001515, 11HE001645, 11HE001647, 11HE001653, 11HE001659, 11HE001838, 11HE001843, 11HE00756; Model# TDXSP-CG-GT, Serial# 11GE001891, 11GE002134, 11GE002849, 11GE003064, 11GE003504; Model# TDXSP-CT-GT, Serial# 11GE002849; Model# TDXSP-MCG, Serial# 11GE000322, 11GE001567, 11GE001894, 11GE002136, 11GE002137, 11GE002372, 11GE002376, 11GE002377, 11GE002378, 11GE002382, 11GE002383, 11GE002385, 11GE002657, 11GE002852, 11GE003065, 11GE003067, 11GE003070, 11GE003073, 11GE003252, 11GE003261, 11GE003263, 11GE003266, 11GE003711, 11GE003712, 11GE003938, 11GE004134, 11GE004135, 11GE004368, 11HE000055, 11HE000102, 11HE000348, 11HE000511, 11HE000761, 11HE001250, 11HE001450, 11HE002071 & 11HE002523.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information Contact Julie Jackson
800-333-6900
Manufacturer Reason
for Recall		 Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Invacare, sent an "URGENT: RECALL INFORMATION" letter dated February 10, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. Invacare has developed retrofit kits intended to address this issue. The consignees were instructed to contact the customers that have potentially affected product and perform the necessary updates. The consignees were also instructed to complete and return the Provider Response Form to order the retrofit kit. If you have any questions, please contact Customer Service at 1-800-333-6900.
Quantity in Commerce 102 wheelechairs
Distribution Worldwide distribution: USA (nationwide) including states of: AZ, CA, CT, FL, GA, IA, IL, IN, KY, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, RI, SD, TX, VA, WA, and WI; and countries of: Australia, Canada and New Zeland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.
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