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U.S. Department of Health and Human Services

Class 1 Device Recall Jaco

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 Class 1 Device Recall Jacosee related information
Date Initiated by FirmAugust 22, 2024
Date PostedOctober 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0049-2025
Recall Event ID 95065
Product Classification Hand, external limb component, powered - Product Code IQZ
ProductKINOVA 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.
Code Information Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.
Recalling Firm/
Manufacturer		 Kinova Inc
355 Peel St Suite 301
Montreal Canada
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 understanding of the recall communication, maintain a detailed list of users, provide the user's contact details to Kinova, and perform an assessment for each user that response to the notification. Distributors were also instructed to complete and return the acknowledgement and response form.
Quantity in Commerce949 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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