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Recall Observatory FDA recall evidence

Device product

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.

Z-0049-2025

August 22, 2024

Class I

Product summary

Firm
Kinova Inc
Event
Event 95065
Status
Ongoing
Classification
Class I
Quantity
949 units
Official record key
device-enforcement:Z-0049-2025

Official wording

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.

Code information: Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.