RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
USRefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Recalling Firm: Reflexion Medical, Inc.
Motif du rappel / Danger
TranslatedDue to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Description du produit & Identification
TranslatedRefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Additional Source Details
| Field | Value |
|---|---|
| City | Hayward |
| State | CA |
| Event id | 98518 |
| Address 1 | 25881 Industrial Blvd |
| Code info | Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013. |
| Postal code | 94545-2991 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 12 |
| Reason for recall | Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260209 |
| Center classification date | 20260327 |
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 RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00?
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 responsableReflexion Medical, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS: CA, TX, PA, CT, NJ, OR, LA, OH
📢 Partager l’alerte
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Reflexion Medical, Inc. - RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 Check if your household is affected: https://therecallfile.com/fr/recalls/reflexion-x1-radiotherapy-system-model-rxm1000-part-800-00006-00/FDA-Z-1656-2026
Rejoindre la liste d’alerte
Recevez des alertes e-mail instantanées dès qu’un rappel critique est publié.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Rappels associés
UKField Safety Notices: 31 August to 4 September 2026
Field Safety Notices: 31 August to 4 September 2026
List of Field Safety Notices from 31 August to 4 September 2026....
AustraliaNutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Vitaco Health Australia Pty Ltd (Vitaco) is alerting customers that sucralose, an artificial sweetener, was used in 23 batches of Nutra-life and Musashi products rather than thaumatin, a natural sweet...
AustraliaAidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Pty Ltd has updated the user manual for the Aspire Active Air 8 Pressure Care Mattress to add setup instructions and warnings about using the device in the presence of oxygen enriched environ...