CLASS II ONGOING Device recall · Reported 23 Sep 2020 · FDA Enforcement Report

Patient Fiducial (Patient Referential) recalled by Imactis

Imactis is recalling Imactis Patient Fiducial (Patient Referential), distributed nationwide in the US. The recall was initiated on 24 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled6 Navigation Systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2972-2020
FDA event ID: 85258
Recalling firm: Imactis, St Martin D Heres, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 24 Aug 2020
FDA classified: 15 Sep 2020
Reported: 23 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

24 Aug 2020	Recall initiated by company
15 Sep 2020	Classified by FDA	+22 days
23 Sep 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

Where it was distributed

US Nationwide distribution including in the states of FL & WI.

Nationwide Florida Wisconsin

Questions about this recall

Is Patient Fiducial (Patient Referential) recalled?

Yes. Imactis recalled Patient Fiducial (Patient Referential) on 24 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-2972-2020.

Why was it recalled?

Which lots are affected?

All Serial Numbers

Where was it sold?

US Nationwide distribution including in the states of FL & WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Imactis

All 3

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24 Mar 2021Device	CLASS II	Impactis NaviKit-stereotaxic accessory recalled by Imactis	Imactis	Labeling Errors	NJ, NY, WI
29 Jan 2020Device	CLASS II	Navigation Kit recalled by Imactis	Imactis	Sterility	IL, WI

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