Imactis Patient Fiducial Recalled Due to Component Separation Risk
Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to improper needle trajectory and navigation failure. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Imactis is recalling the Patient Fiducial (Patient Referential) component, used in conjunction with the ImactisCT-Navigation Workstation. The recall involves 6 Navigation Systems distributed nationwide in the United States, including Florida and Wisconsin.
The recall was initiated after the firm received reports that the patient fiducial disk separated from the body. Users subsequently attempted to re-assemble the device. The use of a re-assembled patient fiducial could lead to an inability to navigate or result in inaccuracies, such as improper needle trajectory.
Healthcare providers and users should stop using the affected components immediately. Imactis is the recalling firm for this Class II recall.
The recalled product
- Product
- Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
- Manufacturer
- Imactis
- Affected units
- 6
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 (1)
- All Serial Numbers
Distribution
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