Recall of Imactis CT-Navigation System by GE Medical Systems

FDA Recalls medium FDA · · United States

GE Medical Systems, LLC is recalling 125 units of the Imactis CT-Navigation System due to a potential issue with needle trajectory accuracy, affecting models E85101LA and E85101LP distributed nationwide in the US.

What this fda recalls alert tells you, and what most readers miss

This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

GE Medical Systems, LLC is recalling the Imactis CT-Navigation System because of a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Which Products Are Affected

The affected products are the Imactis CT-Navigation System, specifically models E85101LA and E85101LP. A total of 125 units are involved. The recall includes various codes such as HIBC: +B681J02000 and multiple IMB codes listed for each model, including IMB-22-013 for E85101LA and IMB-25-005 for E85101LP. Distribution was US Nationwide and worldwide.

What You Should Do

Consumers should contact GE Medical Systems, LLC at their address: 3000 N Grandview Blvd, Waukesha, WI 53188-1615, as the initial notification was via letter. Follow the firm's instructions for the recall, which may include returning the product.

Why This Matters

This recall addresses a potential safety issue in a medical device used for CT-guided procedures, which could affect the accuracy of treatments and patient outcomes.

Source

Information from the FDA recall database, recall number Z-1590-2026.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
GE Medical Systems, LLC is recalling 125 units of the Imactis CT-Navigation System due to a potential issue with needle trajectory accuracy, affecting models E85101LA and E85101LP distributed nationwide in the US.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.