Recall Z-0049-2025— Kinova Inc
Class I · Ongoing
Class I FDA medical device recall by Kinova Inc, initiated 2024-08-22. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Kinova Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-08-22
- Firm location
- Montreal, Canada
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.