Accueil/Tous les Rappels/FDA-Z-0999-2026
FDA DevicesClass II

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Publié le: 14 janvier 2026ID du rappel: Z-0999-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Recalling Firm: Siemens Medical Solutions USA, Inc

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Motif du rappel / Danger

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

Description du produit & Identification

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Additional Source Details

FieldValue
CityMalvern
StatePA
Event id98230
Address 140 Liberty Blvd
Code info(01)04056869269931(21)10330
Postal code19355-1418
Report date20260114
Product typeDevices
Product quantityU.S.: 1, OUS: 95
Reason for recallA potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Voluntary mandatedFDA Mandated
Recall initiation date20251205
Center classification date20260108

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

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 Guide

Q1:What should I do immediately if I own or bought LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471?

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 responsableSiemens Medical Solutions USA, Inc
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionU.S. and OUS
Recall Hazard Severity
High Alert (Class I)
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🚨 SAFETY ALERT: Siemens Medical Solutions USA, Inc - LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Check if your household is affected:
https://therecallfile.com/fr/recalls/luminos-lotus-max-model-11574100-and-luminos-drf-max-model-10762471/FDA-Z-0999-2026
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