GE Medical Systems, LLC has recalled 125 units of the Imactis CT-Navigation System, a stereotaxic accessory used during Computer Tomography (CT) scans. The recall affects Model Numbers E85101LA and E85101LP across various serial numbers. There is a technical issue that can cause a mismatch between where the system simulates a needle should be and where the actual needle tip is positioned during medical procedures. Healthcare providers should stop using these specific navigation units and contact GE HealthCare for further instructions on corrections or returns.
The discordance between simulated and actual needle positions can lead to inaccurate needle placement during CT-guided procedures. This poses a risk of clinicians inadvertently puncturing unintended tissues or organs, potentially leading to patient injury or ineffective treatment.
HIBC code: +B681J02000
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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