Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
USImactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Recalling Firm: GE Medical Systems, LLC
Grund für den Rückruf / Gefahr
TranslatedThere is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
Produktbeschreibung & Identifikation
TranslatedImactis 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Übersicht
- Rückrufendes UnternehmenGE Medical Systems, LLC
- StatusOngoing
- RisikostufeClass II
- DistributionWorldwide distribution - US Nationwide.
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: GE Medical Systems, LLC - Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP Check if your household is affected: https://therecallfile.com/de/recalls/imactis-ct-navigation-system-stereotaxic-accessory-for-computer-tomogr/FDA-Z-1590-2026
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