KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
This recall is currently active, issued October 11, 2024. It was issued by Kinova Inc.
- Company
- Kinova Inc
- Recall Initiated
- August 22, 2024
- Posted
- October 11, 2024
- Recall Number
- Z-0049-2025
- Quantity
- 949 units
- Firm Location
- Montreal Canada
- Official Source
- View on FDA website ↗
Reason for 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.
Distribution
Worldwide - US Nationwide distribution in the states of California, Missouri, North Carolina, Ohio and the countries of Australia, Canada, China, Czechia, France, Germany, Netherlands, Norway, Portugal, Switzerland, Great Britain, Northern Ireland.
Lot / Code Info
Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.
Root Cause
Device Design
Action Taken
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.