GE Medical Systems Imactis CT-Navigation System Recall: Potential Trajectory Mismatch
GE Medical Systems recalls Imactis CT-Navigation System stereotaxic accessories (models E85101LA/E85101LP) due to potential mismatch between simulated and actual needle trajectories during CT procedures.
Lower-risk 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.
Contact the company
What happened, in plain English
GE Medical Systems is recalling Imactis CT-Navigation System stereotaxic accessories for CT scans (models E85101LA and E85101LP) because they may show incorrect needle positions compared to actual positions during procedures. This could lead to inaccurate targeting of medical targets. Read more at govinfonow.com/recall/50054-ge-medical-systems-imactis-ct-navigation-system-recall-potential-trajectory.
Source Summary by GovInfoNow · govinfonow.com/recall/50054-ge-medical-systems-imactis-ct-navigation-system-recall-potential-trajectory · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1590-2026
Cite this page
“GE Medical Systems Imactis CT-Navigation System Recall: Potential Trajectory Mismatch.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50054-ge-medical-systems-imactis-ct-navigation-system-recall-potential-trajectory. Based on FDA recall #Z-1590-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1590-2026%22&limit=1).
Why it’s dangerous
The system may show a discrepancy between the simulated needle path and the actual needle path during CT-guided procedures. This could result in inaccurate targeting of medical targets, potentially affecting treatment outcomes.
Who’s affected
Medical professionals using the Imactis CT-Navigation System for stereotaxic procedures are most at risk. Patients receiving these procedures may be affected if the system is used incorrectly.
How to tell if you have this one
Check for model numbers E85101LA or E85101LP on the Imactis CT-Navigation System stereotaxic accessories. These were sold with specific IMB codes listed in the recall notice.
- Brand
GE Medical Systems- Category
Medical device
What to do — step by step
Check Product Model
Identify if your Imactis CT-Navigation System stereotaxic accessory has model numbers E85101LA or E85101LP.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1590-2026 (February 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1590-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.