Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Recall
- Recall Number
- Z-2972-2020
- Event Number
- 85258
- Firm
- Imactis 20 Rue Du Tour De L Eau St Martin D Heres France
- FEI Number
- 3015060224
- Product Code
- JAK
- Status
- Open, Classified
- Root Cause
- Use error
- Initiated
- August 24, 2020
Description
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
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.
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.
US Nationwide distribution including in the states of FL & WI.
6 Navigation Systems