GE Imactis CT-Navigation System recalled for needle positioning discrepancy
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.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 125 units
- Illnesses reported
- None reported
- Manufactured in
- 3000 N Grandview Blvd, Waukesha, WI, United States
- Classification
- Class II
- Recall number
- Z-1590-2026
In the FDA's words
- Description
- Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. 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 Distribution: Worldwide distribution - US Nationwide. Affected quantity: 125 units
- 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.
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