Correction Notice for Kinova's Jaco Assistive Robotic Arm: Addressing Fire Hazard and Burn Risk Issues

Correction Notice for Kinova’s Jaco Assistive Robotic Arm: Addressing Fire Hazard and Burn Risk Issues

This recall focuses on correcting devices without necessitating their removal from locations of use or sale. The FDA classifies this recall as the most critical type, highlighting that continued use without adjustments may result in significant injury or even death.

Person in a wheelchair with Kinova assistive robotic arm attached on the right.

Product Details

  • Product Name: Jaco Assistive Robotic Arm 
  • Model Numbers: 
    • PJ 0000 0001
    • PJ 0000 0012
    • PJ 0090 0001
    • PJ 0090 0006
    • KR MJ2 0001 
  • Lot/Serial Numbers: All lots   

Recommended Actions

  • Examine the Jaco Arm for absent parts or visible damages including scratches, chips, or cracks on the outer layer.
  • If any damaged components of the Jaco arm contact the wheelchair, immediately disconnect from the power source.
  • Reach out to Kinova Customer Service promptly to evaluate the installation of the wheelchair and arm for this issue and seek help with protective pad installation.

On August 19, 2024, Kinova communicated with every affected customer through an Urgent Medical Device Correction, recommending the following measures: 

For Users

  • Contact Kinova Customer Service to schedule a phone assessment at 514-277-3777 ext. 2, or via email at support@kinova.ca.
  • Disconnect the Jaco arm if any damaged part of it is in contact with the wheelchair.
  • Consult the revised user guide on Kinova’s site.
    • A printed version of this updated guide will be sent to each user in September 2024.
  • Sign and return the acknowledgment and receipt form included in the notification by email or mail to: Kinova Customer Service, 4333 de la Grande Allee Boul., Boisbriand, Quebec, Canada J7H 1M7.

For Distributors

  • Distribute the Urgent Medical Device Correction notice to all Jaco arm users.
  • Verify with Kinova that the User Correction Notice has reached all users.
  • Maintain a record of users, detailing when they were contacted and when they replied.
    • Make three separate attempts to contact users using two distinct methods.
  • Provide Kinova with user contact information, which will solely be used for completing the corrective action.
  • Conduct a video or in-person assessment for each responding user to evaluate and mitigate risks associated with electrical currents flowing through the outer coating of the Jaco arm. Kinova will offer support during these assessments including:
    • Inspection of the robotic arm’s installation.
    • Assessment of the arm for damages.
    • Evaluation of wheelchair integrity as per updated installation protocols.
  • Enforce mitigations, like protective pads to minimize contact between the Jaco arm and metallic components, and ensure updated warnings and requirements are acknowledged.

Rationale for Correction

Kinova is implementing a correction for the Jaco assistive robotic arm because of an elevated fire risk if the arm’s outer coating is compromised and comes into contact with an electrically powered wheelchair displaying electrical leakage due to modifications, damage, or malfunction.

Utilizing the affected product might lead to serious health risks, inclusive of burns, thermal injuries, or fatal outcomes.

No injuries or fatalities have been reported.

Device Purpose

The Jaco assistive robotic arm is designed for individuals who have lost significant or total functionality in their arms. It serves to replace the function of one arm on one side of the body, allowing users to reach, manipulate, and move items. The arm is particularly made to be fitted onto a powered wheelchair and is controlled via the wheelchair’s drive system. 

Contact Information

U.S. customers with queries regarding this recall may contact Kinova Customer Service at 514-277-3777 ext. 2 or email support@kinova.ca.

Further FDA Resources

Unique Device Identifier (UDI)

The UDI plays a crucial role in identifying individual medical devices sold in the U.S., tracking them from manufacturing to patient usage. This system enhances the accuracy in reporting, reviewing, and analyzing adverse events, thereby enabling quicker identification and resolution of potential device issues.

Reporting Issues

Healthcare practitioners and consumers are encouraged to report adverse reactions or quality concerns related to these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.