SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
USSafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Recalling Firm: Alphatec Spine, Inc.
Motif du rappel / Danger
TranslatedIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Description du produit & Identification
TranslatedSafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Additional Source Details
| Field | Value |
|---|---|
| City | Carlsbad |
| State | CA |
| Event id | 98967 |
| Address 1 | 1950 Camino Vida Roble |
| Address 2 | N/A |
| Code info | UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230 |
| Postal code | 92008-6505 |
| Report date | 20260729 |
| Product type | Devices |
| Product quantity | 3 |
| Reason for recall | Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260513 |
| Initial firm notification | N/A |
| Center classification date | 20260723 |
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 SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System?
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.
Vérifiez les autres produits de votre foyer
Outils gratuitsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Aperçu
- Entreprise responsableAlphatec Spine, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution in the states of TX, MO, IN.
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🚨 SAFETY ALERT: Alphatec Spine, Inc. - SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Check if your household is affected: https://therecallfile.com/fr/recalls/safeop-patient-interface-ref-aix11240-part-of-safeop-3-neural-informat/FDA-Z-2793-2026
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