FDA recall Z-0049-2025

Kinova Inc · Class I · 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.

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.

Key facts

Status
Ongoing
Initiation date
2024-08-22
Report date
2024-10-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montreal, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0049-2025