GE Medical Systems, LLC recalls Imactis CT-Navigation System

Recalling company

GE Medical Systems, LLC

Product

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

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 3, 2026

Reported

Apr 1, 2026

Distribution

Worldwide distribution - US Nationwide.

Status

Ongoing

Quantity

125 units

Lot / codes

HIBC: +B681J02000; E85101LA: 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 IMB-20-016 IMB-22-007 IMB-24-002 IMB-20-010 IMB-22-005 IMB-22-017 IMB-24-021 IMB-19-002 IMB-24-017 IMB-20-021 IMB-19-007 IMB-24-014 IMB-24-004 IMB-24-020 IMB-19-013 IMB-20-009 IMB-24-006 IMB-20-008 IMB-24-023 IMB-24-022 IMB-18-009 IMB-19-001 IMB-19-004 IMB-19-006 IMB-19-010 IMB-19-016 IMB-22-001 IMB-22-012 IMB-22-016 IMB-22-018 IMB-17-003 IMB-24-005 IMB-16-007 IMB-22-015 IMB-24-003 IMB-20-002 IMB-20-003 IMB-20-017 IMB-20-018 IMB-20-019 IMB-21-002 IMB-21-004 IMB-22-003 IMB-22-008 IMB-22-009 IMB-20-011 IMB-20-020; 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

Company location

Waukesha, WI

Recall type

Voluntary: Firm initiated

Recall number

Z-1590-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1590-2026 in the FDA Enforcement Report. Also see FDA recall press releases.