HIGH

GE Medical Systems Recalled 125 Imactis CT-Navigation System Stereotaxic Accessories in 2026

GE Medical Systems recalled 125 Imactis CT-Navigation System stereotaxic accessories distributed worldwide to healthcare facilities. The recall cites a potential mismatch between the simulated needle trajectory and the actual trajectory. Healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.

Quick Facts at a Glance

Recall Date
February 3, 2026
Hazard Level
HIGH
Brand
GE Medical Systems
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

Model numbers: E85101LA and E85101LP. Distribution: Worldwide distribution, with US nationwide. Sold to: healthcare facilities. Price: Unknown.

The Hazard

The device has a potential to cause discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position during CT-guided procedures.

Reported Incidents

No injuries or incidents have been reported.

What to Do

1. Stop using the product. 2. Follow recall instructions and contact GE Medical Systems, LLC or your healthcare provider for instructions. 3. Await further directions from the manufacturer or your facility. 4. If you seek a refund or replacement, contact GE Medical Systems, LLC.

Contact Information

Phone: Unknown. Website: Unknown. Hours: Unknown.

Key Facts

  • 125 units recalled
  • Models E85101LA and E85101LP
  • Worldwide distribution
  • Hazard: needle-trajectory discordance
  • Stop use immediately; follow manufacturer instructions
  • Refund/replacement: see Contact Information
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCT navigation system accessory (stereotaxic)
Sold At
Unknown

Product Details

Model Numbers
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
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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