FDA recall, , Moderate risk
GE Medical Systems Imactis CT-Navigation Systems
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC, of Waukesha, Wisconsin, recalled its Imactis CT-Navigation System, a stereotaxic accessory for Computer Tomography (CT) systems, beginning February 3, 2026. The FDA added the recall to its Enforcement Report on March 20, 2026, and it was listed in the weekly enforcement report on April 1, 2026. The recall affects 125 units with worldwide distribution, including nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems
- Model number
- E85101LA
- E85101LP
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide.
- Company
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98447
- Recall number
- Z-1590-2026
- Quantity recalled
- 125 units
All recalls from GE Medical Systems, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
