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Kinova Inc - Jaco - Class 1 Recall


Kinova Inc - Jaco - Class 1 Recall

Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.On 07/22/2024, Kinova notified consignees via UGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed contact Kinova immediately for an assessment, ensure that if the wheelchair is in contact with a damaged part of the Jaco arm in any position at any time, to unplug the Jaco arm from the power source immediately and contact Kinova, and read the updated user guide on Kinova's website. Consignees were also requested to complete and return the acknowledgement and response form. Distributors were instructed to communicate the recall to all Jaco users, confirm receipt and understanding of the recall communication, maintain a detailed list of users, provide the user's contact details to Kinova, and perform an assessment for each user that response to the notification. Distributors were also instructed to complete and return the acknowledgement and response form.

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