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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Power Wheelchair

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 Class 2 Recall
Invacare Power Wheelchair
see related information
Date Posted September 23, 2013
Recall Status1 Open
Recall Number Z-2270-2013
Recall Event ID 65348
Premarket Notification
510(K) Numbers
K023589  K993413 
Product Classification Wheelchair, Powered - Product Code ITI
Product Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Code Information The following Joystick model numbers and respective part numbers are affected by this recall: CSPJ, 1121239; SPJPLUS, 1127291; SPJAP, 1136937; SPJAPM, 1136938; CMPJM6, 1164361; CMPM6U, 1644361; MPJM6, 1136885; MPJM6U, 1136885; 1558M6, 1136887; 1558MM6, 1136887; 1500M6, 1136889; PACM6, 1136888; PACM6, 1167927; PSRM6, 1139941; PSRM6, 1140046; PSRM6, 1140047; PSRM6, 1140048; PSRM6, 1144844; PSRM6, 1144845; and PSFM6, 1139944. The following Power Wheelchair model numbers (affected date ranges are included in the 1525712 6-3-13 001C model numbers FINAL xlsx document) are affected by this recall: M61UKRD; 3GAR; 3GARBASE; 3GAR-CG; 3GRX; 3GRXBASE; 3GRX-CG; 3GSEAT-CG; 3GSTRX-TS; 3GTQ3; 3GTQ3-CG; 3GTQ3-MCG; 3GTQ3V; 3GTQ-CG; 3GTQ-MCG; 3GTQSE; 3GTQSEBASE; 3GTQSE-CG; 3GTQSE-PTO; 3GTQSP; 3GTQSPBASE; 3GTQSP-TS; FDX; FDX-CG; FDX-MCG; M41BB; M41RB; M41RBCN; M51 PBLUEBASE; M51 PREDBASE; M51BB; M51-CG; M51CGBB; M51CGRB; M51P; M51PBB; M51PBLUEBASE; M51PR; M51PRB; M51PREDBASE; M51RB; M51RBCN; M51SEAT-CG; M61; M61 PBLUE; M61 PRED ; M61 ; KRDBASE; M61(1144227); M61FBLUE; M61FRAD; M61FRED; M61R; M61RB(1144227); M61RBCN; M61RED; M61SEAT; M61UK; M61UK REDBASE; M61UKRD; M61UKRDBASE; M71; M71JR; M71R; M71SEAT; M71-TS; M91; M91-C; M91-M; M91R; M91-R; M91SEAT; M91-TS; M94; M94-C; PTBASE; PTORB; PWORBITS; R51; R51LXP; TDX3; TDX3BASE; TDX3-PS; TDX3SE; TDX3SEBASE; TDX3SE-PS; TDX3SE-TS; TDX3-TS; TDX4; TDX4BASE; TDX4-PS; TDX4-TS; TDX5; TDX5BASE; TDX5-PS; TDX5-TS; TDXSC; TDXSC2-CG; TDXSCSEAT; TDXSCV; TDXSEAT; TDXSI; TDXSI-2; TDXSI-2-S; TDXSI-CG; TDXSI-HD; TDXSI-HD-S; TDXSISEAT; TDXSISEAT-HD; TDXSIV; TDXSIV-2; TDXSIV-2-S; TDXSIV-HD; TDXSIV-HD-S; TDXSP; TDXSPBASE; TDXSP-CG; TDXSP-CG-GT; TDXSP-GT; TDXSP-MCG; TDXSP-MCG-GT; TDXSPREE; TDXSPREE-CG; TDXSPREESEAT; TDXSPSEAT; TDXSR; TDXSR-CG; TDXSR-CG-HD; TDXSR-HD; TDXSR-MCG; TDXSR-MCG-HD; TDXSRSEAT; TDXSRV; and TDXSRV-HD.
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria, Ohio 44035-6248
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Invacare sent an Urgent Patient Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their wheelchair povider to have their joystick replaced. Customers with questions were instructed to call their provider at Invacare's recall support line at 877-413-6008. Go to www.invacare.com/joystickrecall for more information regarding this recall.
Quantity in Commerce 166,230
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada, Australia, Bermuda, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.
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