FDA DevicesClass II

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

Publicado: 29 de julio de 2026ID de Retiro: Z-2775-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

Recalling Firm: KENT IMAGING, INC.

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Motivo del Retiro / Peligro

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

Descripción del Producto e Identificación

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

Additional Source Details

FieldValue
CityCalgary
StateN/A
Event id99406
Address 11210 8 St Sw Suite 300
Address 2N/A
Code infoUDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3
Postal codeN/A
Report date20260729
Product typeDevices
Product quantity77
Reason for recallThe software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260630
Initial firm notificationN/A
Center classification date20260722

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 SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.?

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 ResponsableKENT IMAGING, INC.
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: KENT IMAGING, INC. - SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

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https://therecallfile.com/es/recalls/snapshotglo-wound-imaging-device-model-kb100-kb100aa/FDA-Z-2775-2026
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