Imactis NaviKit Stereotaxic Accessory Recalled for Mechanical Defect
Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that could cause damage to organs or vasculature, meeting the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Imactis is recalling 105 units of the NaviKit-stereotaxic accessory for Computed Tomography systems (Reference # I10100). The recall affects lots 20060001 and 20060005, with UDI-DI B681I101002. The product was distributed in New Jersey, New York, and Wisconsin.
The recall is due to a defect in the mechanical assembly of the needle holder contained in the navigation kit. Specifically, one of the two jaws of the needle holder does not provide gripping functionality. If this defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation. This may result in an inaccurate needle position, which could cause damage to organs or vasculature adjacent to the needle trajectory.
Healthcare facilities and users should stop using the affected NaviKit-stereotaxic accessories immediately. Imactis is the recalling firm responsible for managing the recall. Users should contact Imactis for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Manufacturer
- Imactis
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots #: 20060001
- 20060005 UDI-DI: B681I101002
Distribution
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