Z-1590-2026Class II

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers...

Name: Z-1590-2026 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers...
Creator: GE Medical Systems, LLC
Published: 2026-02-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-02-03 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP on 2026-02-03. FDA classified it as Class II and gives the reason as "There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1590-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-03
Posted: 2026-03-20
Recalling firm: GE Healthcare
Product: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: design
FDA 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 safety notification and the required actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected] 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.
Quantity in commerce: 125 units
Distribution: Worldwide distribution - US Nationwide.
Product codes and 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 IMB-20-020; E85101LP: IMB-25-005 IMB-21-007 IMB-25-007 IMB-25-008 IMB-20-001 IMB-20-013 IMB-25-012 IMB-25-009 IMB-25-006 IMB-21-009 IMB-25-013 IMB-25-010 IMB-19-012 IMB-25-001 IMB-25-004 IMB-24-024 IMB-25-023 IMB-25-003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1590-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1590-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20

Product code JAK

K162314Class IIIMACTIS CT-Navigation systemImactis, Sas / cleared 2018-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)