Recall of Imactis CT-Navigation System by GE Medical Systems
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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 recall 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,161 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.