FDA Medical Device Recalls (openFDA)
Imactis: Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
- Recall number
- Z-2972-2020
- Recalling firm
- Imactis
- Product
- Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
- Status
- Open, Classified
- Initiated
- 2020-08-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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 quality@imactis.com 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
- 6 Navigation Systems
- Distribution
- US Nationwide distribution including in the states of FL & WI.
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K162314"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3015060224
- Firm city
- Heres
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28