Recall Z-0049-2025 ยท IQZ Hand, External Limb Component, Powered
Kinova Inc
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.
| Date | Oct 11, 2024 (initiated Aug 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 understandi |
| Quantity | 949 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.