INVACARE® TDX® POWER WHEELCHAIR

Technical Specs

MRI safety

Labeling does not contain MRI Safety Information

Sterile

No

Single use

No

Prescription use

Rx only

FDA distribution status

Not in Commercial Distribution

Device type (GMDN)

Electric-motor-driven wheelchair, occupant-controlled

FDA product classification

Wheelchair, powered

Manufacturer support

+1(440)329-6000 · orders@invacare.com

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Varies by device - check the unit's own manual for facility placement guidance

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

• RECALL

  Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

• RECALL

  Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolved, the caster may separate from the base of the lift causing the Lift to tilt and a patient fall. Failure does not occur right away but happens over time if the lift is not properly maintained. Patient falls are inherently dangerous and may result in a range of injuries that are dependent on physical condition of the patient and the nature of the fall. When injuries occur, they are typically non-serious injuries such as bruising, lacerations, or abrasions. In rare cases, more serious injuries such as bone fracture, head trauma, or death can occur. For caregivers using the lift, attempts to manually stabilize a lift if it becomes unstable could result i

• RECALL

  The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

• RECALL

  If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.

• RECALL

  Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

• 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.

• 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.

• RECALL

  For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for

• RECALL

  Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.

• RECALL

  Software error may permit the chair to recline too far.

• RECALL

  When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.

• RECALL

  If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.