Safety
The FDA rated the Jaco fire-risk correction as the most serious type of recall.
A crash, recall, injury or investigation
What the source says
“The FDA has identified this recall as the most serious type.”
What it means
Assistive robot arms, from Kinova, Assistive Innovations, is at stage 4 of 5 on our ladder: paying customers. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: Our sources report it working without human help.
More on Assistive robot arms
- Molina's policy treats these arms as unproven and does not count them as medically necessary, saying there is not enough research on long-term safety and benefit.
- The FDA puts these arms in its lowest-risk class (Class I), so they do not need FDA clearance before sale.
- US insurer Molina Healthcare names Kinova's Jaco and Assistive Innovations' iARM as the arms on the market today.
- California's Medi-Cal health plan began covering assistive robot arms as a benefit.
- Kinova sent all Jaco customers an urgent correction notice because a damaged outer coating on the arm could raise the risk of fire if it touches a wheelchair with an electrical fault. All lots were affected; no injuries or deaths were reported.
- More than 150 people in the Netherlands were feeding themselves with a Jaco arm.