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U.S. Department of Health and Human Services

Class 2 Device Recall Imactis CTNavigation Workstation

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 Class 2 Device Recall Imactis CTNavigation Workstationsee related information
Date Initiated by FirmAugust 24, 2020
Create DateSeptember 15, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2972-2020
Recall Event ID 85258
510(K)NumberK162314 
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Imactis
20 Rue Du Tour De L Eau
St Martin D Heres France
For Additional Information ContactMr. Robert Hornak
205-5421486
Manufacturer 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 Determined
Cause 2		Use error
ActionOn 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 in Commerce6 Navigation Systems
DistributionUS Nationwide distribution including in the states of FL & WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
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