The robotics company Kinova has issued an Urgent Medical Device Correction notice for their Jaco Assistive Robotic Arm due to fire and burn risks. The FDA considers this a Class 1 recall, since continued use of the device without the proposed corrections could cause serious injury or death.
The Jaco Assistive Robotic Arm is used by people who have lost the use of their arms. The device typically works in conjunction with electrically powered wheelchairs, allowing users to manipulate the robotic arm through the drive control on the wheelchair.
Kinova announced the recall on August 19, 2024, and released instructions for both users and distributors. The recall applies to all lots of the following five models of the Jaco Assistive Robotic Arm: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, and KR MJ2 0001. To start, Kinova sent a letter to all users, advising them to make a visual assessment of the Jaco arm for any type of damage to the outer coating. If damage is detected, and the arm is in contact with an electrically powered wheelchair, users should immediately disconnect the arm from the power source. After disconnecting the arm, users should contact Kinova Customer Service at 514-277-3777 (ext. 2) or by email at support@kinova.ca to arrange for an assessment, which might include installation of a protective pad to prevent injury.
The company also provided specific instructions to distributors of the Jaco Assistive Robotic Arm. First, Kinova advised distributors to make three attempts at contacting all users to ensure they are aware of and have received a copy of the company’s Urgent Medical Device Correction letter. Kinova asks that distributors maintain a list, tracking the dates of contact, and that they provide that list to Kinova so that appropriate actions can be taken to assist those customers who’ve reported damage to the outer coating of their Jaco arm. As customers respond, Kinova asks distributors to provide in-person or remote assessments of all reported Jaco arms to identify the risk of electrical leakage and injury. Finally, the company will provide distributors with protective pads, which can be installed with all affected Jaco arms to minimize the risk of electrical leakage. Kinova is available to provide remote support to all distributors as they work with users directly.
Kinova asks that users return the acknowledgement and receipt form included with the Urgent Medical Device Correction letter and return it to support@kinova.ca. Alternately, users can mail the form to Kinova Customer Service, 4333 de la Grande Allee Boul., Boisbriand, Quebec, Canada J7H 1M7.
Anyone with questions or concerns about the recall can contact Kinova at 514-277-3777 (ext. 2) or by email at support@kinova.ca.
Patients and health care providers can report any new adverse health events related to Kinova’s Jaco Assistive Robotic Arm through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of the Jaco Assistive Robotic Arm, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.