ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
USARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Recalling Firm: Siemens Medical Solutions USA, Inc
Motivo del Retiro / Peligro
TranslatedDuring patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Descripción del Producto e Identificación
TranslatedARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98992 |
| Address 1 | 40 Liberty Blvd |
| Code info | ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325 |
| Postal code | 19355-1418 |
| Report date | 20260610 |
| Product type | Devices |
| Reason for recall | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20260309 |
| Center classification date | 20260604 |
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 ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTI...?
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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Resumen
- Empresa ResponsableSiemens Medical Solutions USA, Inc
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS and Worldwide
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🚨 SAFETY ALERT: Siemens Medical Solutions USA, Inc - ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system Check if your household is affected: https://therecallfile.com/es/recalls/artis-icono-biplane-floor-and-ceiling-artis-icono-biplane-model-113276/FDA-Z-2206-2026
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