Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting...
FDA Device Recall #Z-2270-2013 — Class II — June 4, 2013
Recall Summary
| Recall Number | Z-2270-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 4, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invacare Corporation |
| Location | Elyria, OH |
| Product Type | Devices |
| Quantity | 166,230 |
Product Description
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
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.
Distribution Pattern
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.
Lot / 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.
Other Recalls from Invacare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1251-2024 | Class II | Invacare Homecare Series Bed and Invacare G-Ser... | Jan 22, 2024 |
| Z-2445-2023 | Class II | DOLOMITE GLOSS ROLLATOR - intended to support d... | Jun 15, 2023 |
| Z-1369-2022 | Class III | Invacare Platinum 5NXG Oxygen Concentrator, Mod... | Jun 10, 2022 |
| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG... | Mar 30, 2022 |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchai... | Nov 12, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.