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.
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
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.
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.
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.
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.
Identify if your Imactis CT-Navigation System stereotaxic accessory has model numbers E85101LA or E85101LP.
The system may show a discrepancy between the simulated needle path and the actual needle path during CT-guided procedures, potentially leading to inaccurate targeting of medical targets.
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.
The recall does not specify a remedy, so contact GE Medical Systems directly for guidance on next steps.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1590-2026 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1590-2026 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.