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Kinova Issues Urgent Correction for Jaco Assistive Robotic Arm Due to Fire Hazard and Burn Risk

The Kinova Jaco Assistive Robotic Arm is a medical device. The company designed it to help individuals with limited arm functionality perform everyday tasks. 

FDA issued “an urgent medical device correction” due to serious safety concerns. Kinova, the company behind the robotic arm, initiated a correction program after identifying risks associated with certain models. This program does not involve removing the device from users but instead focuses on inspecting and correcting any existing issues. The U.S. Food and Drug Administration (FDA) has categorized this correction as a Class I recall, the most serious type, as continued use of an affected device without correction may lead to severe injury or even death. We’re not medical professionals, so speak with your healthcare professional.

In this article, we will cover what you need to know about the affected product, what actions users and distributors should take, and why this correction is necessary. If you or a loved one uses the Kinova Jaco Assistive Robotic Arm, read on for essential information to ensure your safety.

What Kinova Products are Subject to the Notice?

The recall specifically applies to the Kinova Jaco Assistive Robotic Arm and includes several model numbers:

• Model Numbers:
• PJ 0000 0001
• PJ 0000 0012
• PJ 0090 0001
• PJ 0090 0006
• KR MJ2 0001

All lots and serial numbers of these models are affected by this correction.

The Kinova Jaco Assistive Robotic Arm is intended to be mounted on a motorized wheelchair, enabling individuals with significant arm mobility limitations to reach, grasp, and manipulate objects. This device significantly enhances the independence of users by performing basic functions that would otherwise be difficult or impossible. However, due to the recent findings of potential safety risks, it is crucial for users and caregivers to follow the correction steps Kinova.

Reason for Correction

Kinova is issuing this correction because of a discovered risk of fire and burn hazards linked to the device. We worry about potential burn injuries.

The outer coating of the arm, if damaged, may pose a risk when it comes into contact with an electrically powered wheelchair that has electrical leakage due to modifications, damage, or malfunction. In such cases, the electrical current could travel through the arm’s coating, leading to overheating, fire hazards, or even electric shock. These situations can cause severe injuries, including burns and other thermal injuries, or even death in extreme cases.

Currently, no injuries or deaths have been reported due to this issue. We appreciate that Kinova is taking proactive measures to ensure user safety and prevent potential incidents.

What Are Immediate Actions for Users?

Kinova has provided a list of recommended actions for users of the Jaco Assistive Robotic Arm. If you are a user or caregiver of someone using this device, follow these steps immediately:

1. Inspect the Device for Damage:

Carefully examine the Jaco Assistive Robotic Arm for any visible damage, such as scratches, chips, cracks, nicks, or missing parts on the outer coating. Any of these signs could indicate potential risk.

2. Unplug the Arm from Power Source When Necessary:

If the arm’s damaged part comes into contact with the wheelchair, unplug it from the power source immediately to minimize the risk of electrical flow and potential hazards.

3. Contact Kinova Customer Service:

Reach out to Kinova Customer Service for assistance and to arrange an assessment. You can contact them by phone at 514-277-3777 ext. 2 or via email at support@kinova.ca. Kinova will help with a detailed evaluation and provide additional guidance on mitigating risks.

4. Read the Updated User Guide:

Kinova has issued an updated user guide available on their website, with a printed version set to be sent to all affected users by September 2024. Make sure to review this guide for detailed instructions on using the device safely.

5. Return the Acknowledgement Form:

Each user has been sent an acknowledgement and receipt form with the correction notice. Be sure to complete and return this form to Kinova by email or mail, confirming you have received and understood the correction notice.

Steps for Distributors

Kinova also has specific instructions for distributors of the Jaco Assistive Robotic Arm. If you are a distributor, follow these steps to ensure the correction notice reaches all users:

1. Share the Correction Notice:

The notice recommends distributors to send the Urgent Medical Device Correction notice to all users of the Jaco Assistive Robotic Arm and confirm with Kinova that they shared the notice.

2. Maintain Contact Records:

Keep a detailed record of users and when you contacted them. Make three attempts to reach each user using two different communication methods, such as email and phone.

3. Submit User Contact Information:

Provide Kinova with user contact details, including names, phone numbers, emails, and addresses. They should use this information strictly for completing the correction action and ensuring user safety.

4. Conduct User Assessments:

For each user who responds, perform a video or in-person assessment of the Jaco Arm. This includes inspecting the arm’s installation, checking for visible damage, and ensuring wheelchair integrity. Kinova states it will support these assessments remotely and help review both user and installation guides.

5. Implement Safety Mitigations:

As part of the assessment, apply protective pads to reduce direct contact between the Jaco arm and other metallic parts of the wheelchair. Ensure users acknowledge and understand the updated warnings and safety instructions.

Long-Term Safety Recommendations

Kinova’s proactive steps to correct the Jaco Assistive Robotic Arm underline the importance of regular inspections and maintenance for assistive devices. For users, it’s vital to monitor your device’s condition continuously, even beyond this recall. Regular maintenance and timely reporting of any damage can prevent potential risks and ensure your device operates safely.

If you are a caregiver, advocate, or user, staying informed about any recalls or corrections issued for medical devices is essential for safety. Always keep an open line of communication with manufacturers and don’t hesitate to reach out if you notice any issues with assistive devices.

How KBA Attorneys Can Help

If you or a loved one has been affected by the Kinova Jaco Assistive Robotic Arm and experienced harm due to its use, consider reaching out to KBA Attorneys. Our team handles cases involving defective medical devices. KBA fights to ensure that manufacturers uphold the highest standards of safety and accountability. We understand the profound impact such devices have on users’ daily lives. Contact KBA Attorneys for a free consultation to discuss your situation and explore your legal options.