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FDA DevicesClass II

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Publié le: 29 avril 2026ID du rappel: Z-1918-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Recalling Firm: Micro-X Ltd.

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Description du produit & Identification

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Produits concernés

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Additional Source Details

FieldValue
CityTonsley
StateN/A
Event id98644
Address 1Unit 14 6 Mab Eastern Promenade
Address 2N/A
Code infoLot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Postal codeN/A
Report date20260429
Product typeDevices
Product quantity32 units
Reason for recallX-Ray generator may malfunction resulting in the X-Ray being inoperable.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260327
Initial firm notificationE-Mail
Center classification date20260422

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 Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71?

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 responsableMicro-X Ltd.
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionUS Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Recall Hazard Severity
High Alert (Class I)
Alerte officielle de l’agence

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Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: Micro-X Ltd. - Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Check if your household is affected:
https://therecallfile.com/fr/recalls/rover-mobile-x-ray-system-model-catalog-number-mxu-rv35-and-mxu-rv71/FDA-Z-1918-2026
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