Recall Z-1590-2026
GE Medical Systems, LLC · initiated February 3, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Codes / lots: HIBC: +B681J02000; E85101LA: IMB-22-013 IMB-24-013 IMB-23-006 IMB-24-001 IMB-24-016 IMB-24-018 IMB-24-007 IMB-21-001 IMB-23-004 IMB-24-015 IMB-22-014 IMB-22-011 IMB-21-008 IMB-22-010 IMB-23-003 IMB-22-002 IMB-16-005 IMB-16-002 IMB-17-007 IMB-21-003 IMB-16-003 IMB-18-006 IMB-16-006 IMB-19-014 IMB-23-007 IMB-19-011 IMB-24-011 IMB-15-001 IMB-24-009 IMB-20-005 IMB-19-009 IMB-15-003 IMB-18-007 IMB-17-011 IMB-18-003 IMB-19-003 IMB-17-006 IMB-20-004 IMB-21-005 IMB-21-006 IMB-20-012 IMB-22-004 IMB-17-008 IMB-20-022 IMB-19-019 IMB-18-004 IMB-17-012 IMB-19-008 IMB-15-004 IMB-16-004 IMB-17-005 IMB-18-002 IMB-18-005 IMB-18-010 IMB-19-005 IMB-15-002 IMB-17-009 IMB-17-010 IMB-24-012 IMB-17-002 IMB-20-016 IMB-22-007 IMB-24-002 IMB-20-010 IMB-22-005 IMB-22-017 IMB-24-021 IMB-19-002 IMB-24-017 IMB-20-021 IMB-19-007 IMB-24-014 IMB-24-004 IMB-24-020 IMB-19-013 IMB-20-009 IMB-24-006 IMB-20-008 IMB-24-023 IMB-24-022 IMB-18-009 IMB-19-001 IMB-19-004 IMB-19-006 IMB-19-010 IMB-19-016 IMB-22-001 IMB-22-012 IMB-22-016 IMB-22-018 IMB-17-003 IMB-24-005 IMB-16-007 IMB-22-015 IMB-24-003 IMB-20-002 IMB-20-003 IMB-20-017 IMB-20-018 IMB-20-019 IMB-21-002 IMB-21-004 IMB-22-003 IMB-22-008 IMB-22-009 IMB-20-011…
Reason for recall
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
FDA-determined cause: Device Design
Action taken
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 safety notification and the required actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.27001@gehealthcare.com or use the QR code to submit your response electronically. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-1590-2026
- Initiated
- February 3, 2026
- Posted by FDA
- March 20, 2026
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Quantity
- 125 units
- Distribution
- Worldwide distribution - US Nationwide.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI