Recall Z-2972-2020 ยท JAK System, X-Ray, Tomography, Computed
Imactis
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
| Date | Aug 24, 2020 |
| Status | Open, Classified |
| 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 |
| Quantity | 6 Navigation Systems |
| Distribution | US Nationwide distribution including in the states of FL & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162314 | IMACTIS CT-Navigation system Imactis, Sas, Apr 24, 2018 |