Reported Apr 1, 2026 · Ongoing

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and…

GE Medical Systems, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

Lot codes and dates: HIBC+B681J02000
E85101LA
107 of 107 codes
IMB-22-013
IMB-24-013
IMB-23-006
IMB-24-001
IMB-24-016
IMB-24-018
IMB-24-007
IMB-21-001
IMB-23-004
IMB-24-015
IMB-22-014
IMB-22-011
IMB-21-008
IMB-22-010
IMB-23-003
IMB-22-002
IMB-16-005
IMB-16-002
IMB-17-007
IMB-21-003
IMB-16-003
IMB-18-006
IMB-16-006
IMB-19-014
IMB-23-007
IMB-19-011
IMB-24-011
IMB-15-001
IMB-24-009
IMB-20-005
IMB-19-009
IMB-15-003
IMB-18-007
IMB-17-011
IMB-18-003
IMB-19-003
IMB-17-006
IMB-20-004
IMB-21-005
IMB-21-006
IMB-20-012
IMB-22-004
IMB-17-008
IMB-20-022
IMB-19-019
IMB-18-004
IMB-17-012
IMB-19-008
IMB-15-004
IMB-16-004
IMB-17-005
IMB-18-002
IMB-18-005
IMB-18-010
IMB-19-005
IMB-15-002
IMB-17-009
IMB-17-010
IMB-24-012
IMB-17-002
E85101LP
IMB-25-005
IMB-21-007
IMB-25-007
IMB-25-008
IMB-20-001
IMB-20-013
IMB-25-012
IMB-25-009
IMB-25-006
IMB-21-009
IMB-25-013
IMB-25-010
IMB-19-012
IMB-25-001
IMB-25-004
IMB-24-024
IMB-25-023
IMB-25-003
Amount recalled: 125 units

Where it was sold

Nationwide

Why it was recalled

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

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36 in total.

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