FDA-Device2026-04-01Class IIPROCESSING DEFECT
GE Imactis CT-Navigation System recalled for needle positioning discrepancy
OTHERNationwide distribution
Stop using affected GE Imactis CT-Navigation systems
GE Medical Systems' Imactis CT-Navigation System (Models E85101LA and E85101LP) has a potential issue where the needle's simulated path shown to the doctor may not match where the needle actually goes during CT-guided procedures. This discrepancy could affect the accuracy of needle placement during medical procedures. No injuries have been reported.
- If your facility uses this device, contact GE Medical Systems for instructions and updates
- Do not use affected units until you receive guidance from the manufacturer or FDA
- Check your device model number (E85101LA or E85101LP) and serial number against the recall list
Hazard
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
Sold states
Worldwide distribution - US Nationwide.
Affected count
125 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1590-2026More GE Medical Systems, LLC recalls
- FDA-Device2026-05-20GE Revolution CT ES X-ray systems recalled for AW Server security vulnerability
- FDA-Device2026-05-20GE Revolution Apex Elite CT scanner recalled for AW Server security vulnerability
- FDA-Device2026-05-20GE Revolution Apex CT scanner recalled for AW Server security vulnerability
- FDA-Device2026-05-20GE Revolution Apex Plus CT scanner recalled for AW Server security vulnerability
- FDA-Device2026-05-20GE Revolution CT systems recalled for AW Server security vulnerability
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