Z-2972-2020Class II

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the...

Name: Z-2972-2020 Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the...
Creator: Imactis
Published: 2020-08-24
License: https://open.fda.gov/license/

Imactis, SAS / initiated 2020-08-24 / Open, Classified

FDA source

Imactis began a recall of Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180) on 2020-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2972-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-24
Posted: 2020-09-15
Recalling firm: Imactis, SAS
Product: Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Use error
Action: On 08/XX/2020, affected consignees where emailed a copy of the "Urgent - Medical Device Correction" notification. In addition, a paper copy will be provided to each consignee in person by the end of August 2020. In addition to providing information on the correction, the notification asked consignees to take the following actions: 1. Inspect your patient fiducial for potential separation and confirm to us, using the attached acknowledgement of receipt (See Exhibit A). - The fiducial disk is normally flush with the surface. Check the fiducial disk to determine that it is at the same level as the fiducial body. If the fiducial disk is raised from the body surface, then there is a separation. 2. If disk separation is noticed: - Remove the CT-Navigation" workstation from service. - Immediately contact your IMACTIS representative for repair or replacement - Robert Hornak - 205-542-1486 (cell), Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time 3. A warning label will be sent to your facility and must be affixed to the IMACTIS CT-Navigation" workstation (See attached Exhibit B). 4. Complete the Exhibit A "Acknowledgement of Receipt of Important Customer Information" and email to [email protected] 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 6 Navigation Systems
Distribution: US Nationwide distribution including in the states of FL & WI.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2972-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2972-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-23	2020-09-15

Product code JAK

K162314Class IIIMACTIS CT-Navigation systemImactis, Sas / cleared 2018-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)