FDA DevicesClass II
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT)...
Published: April 1, 2026Recall ID: Z-1590-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98447 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | 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... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 125 units |
| Reason for recall | There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260203 |
| Initial firm notification | Letter |
| Center classification date | 20260320 |
Overview
- Recalling FirmGE Medical Systems, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide.