This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names: Jaco Assistive Robotic Arm
- Models:
- PJ 0000 0001
- PJ 0000 0012
- PJ 0090 0001
- PJ 0090 0006
- KR MJ2 0001
- Lot/Serial Numbers: All lots
What to Do
- Inspect the Jaco Arm for missing parts or scratches, chips, cracks, nicks, or other visible damage to the outer coating of the arm.
- Unplug the Jaco arm from the power source if the wheelchair is in contact with a damaged part of the Jaco arm at any time during use.
- Contact Kinova Customer Service as soon as possible to have the wheelchair and arm installation assessed for this issue and for assistance with protective pad installation.
On August 19, 2024, Kinova sent all affected customers an Urgent Medical Device Correction recommending the following actions:
For users
- Contact Kinova Customer Service as soon as possible to arrange for an assessment by phone at 514-277-3777 ext. 2 or by email at support@kinova.ca.
- Unplug the Jaco arm immediately if the wheelchair is in contact with a damaged part of the Jaco arm in any position at any time.
- Read the updated user guide found on Kinova’s website.
- Kinova will send a printed copy of this updated user guide to every user in September 2024.
- Return the acknowledgement and receipt form attached to the letter and return by email to support@kinova.ca or by mail to: Kinova Customer Service, 4333 de la Grande Allee Boul., Boisbriand, Quebec, Canada J7H 1M7.
For distributors
- Share the Urgent Medical Device Correction notice with all Jaco arm users.
- Confirm to Kinova that the User Correction Notice was sent to all users.
- Keep a detailed list of users, when they were contacted, and when they responded.
- Make three attempts using two different communication methods to contact users.
- Provide user contact details (name, phone, email, address) to Kinova. This information will be used only to complete the field corrective action.
- Complete a video or in-person assessment for each user who responded to the notice to identify and mitigate the risk that electrical current could flow through the outer coating of the Jaco arm. Kinova will provide remote support for conducting these assessments and review the user and installation guides during each user’s assessment which will include:
- Assessing the robotic arm’s installation.
- Reviewing the robotic arm for damage.
- Assessing wheelchair integrity based on updated installation requirements.
- Implement mitigations (i.e. protective pads) to minimize contact between the Jaco arm and other metallic parts and ensure that updated warnings and requirements are acknowledged.
Reason for Correction
Kinova is correcting the Jaco assistive robotic arm due to an increased fire hazard if the outer coating of the arm has any damage and makes contact with an electrically powered wheelchair that has electrical leakage from modifications, damage, or malfunction.
The use of affected product may cause serious adverse health consequences, including burns, other thermal injuries, and death.
There have been no reported injuries and no reports of death.
Device Use
The Jaco assistive robotic arm is intended for use by people who have lost most or all functionality of their arms. The arm replaces the function of one arm on a single side of the body by allowing the user to reach, move, and manipulate objects. It is designed to be installed on a motorized wheelchair and is controlled through the wheelchair’s drive control.
Contact Information
Customers in the U.S. with questions about this recall should contact Kinova Customer Service at 514-277-3777 ext. 2 or by email at support@kinova.ca.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
