MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
USMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Recalling Firm: Elekta, Inc.
Motif du rappel / Danger
TranslatedUsing oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Description du produit & Identification
TranslatedMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Produits concernés
TranslatedMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98116 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| Code info | MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071 |
| Postal code | 30346-1227 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251210 |
| Center classification date | 20260113 |
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 MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)?
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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Aperçu
- Entreprise responsableElekta, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution in the state of TX.
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🚨 SAFETY ALERT: Elekta, Inc. - MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Check if your household is affected: https://therecallfile.com/fr/recalls/mosaiq-oncology-information-system-with-particle-therapy-license-licen/FDA-Z-1078-2026
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