Recall Z-1590-2026 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
| Date | Mar 20, 2026 (initiated Feb 3, 2026) |
| Status | Open, Classified |
| Reason | There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 2/3/26 was sent to customers. Actions to be taken by Customer / User You can continue to use your system if you DO NOT use needles with metal handles or metal hubs. A User Manual addendum is included with this letter (see Appendix A) that includes specific instructions to avoid the use of needles with metal handles or metal hubs. Please place a copy of the addendum in Appendix A with the User Manual for each Imactis CT Navigation" system in your facility. Please ensure all potential users in your facility are made aware of this saf |
| Quantity | 125 units |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162314 | IMACTIS CT-Navigation system Imactis, Sas, Apr 24, 2018 |