Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position
Invacare Corporation began a recall of Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position on . FDA classified it as Class II and gives the reason as "Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2270-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Invacare GmbH
- Product
- Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
- Product code
- ITI Wheelchair, Powered
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- 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.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2270-2013 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
