Z-2775-2026Class II

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA

Name: Z-2775-2026 SnapshotGLO Wound Imaging Device, Model KB100, KB100AA
Creator: Kent Imaging, Inc.
Published: 2026-06-30
License: https://open.fda.gov/license/

Kent Imaging Inc / initiated 2026-06-30 / Open, Classified / root cause: software

FDA source

KENT IMAGING, INC. began a recall of SnapshotGLO Wound Imaging Device, Model KB100, KB100AA on 2026-06-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2775-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-07-22
Recalling firm: Kent Imaging Inc
Product: SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
Product code: QJF Autofluorescence Imaging Adjunct Tool For Wounds
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On 6/30/2026, correction and removal notices were emailed to customers who were asked to do the following: 1) Discontinue use of the affected unit(s) and remove them from clinical service. 2) Contact Kent Imaging at [email protected] to confirm return shipping instructions. 3) Pending return, keep the device charged and avoid allowing the battery to fully deplete, to prevent the unit from becoming temporarily inoperable in the interim. 4) Within 5 business days of receipt of this notice, please confirm receipt and current status of the listed unit(s) by replying to this letter or contacting Hitalo Arume directly. Distributor was asked to: a) Identify the current location/holder of each of these 6 units; b) Coordinate scheduling of a brief remote session between Kent Imaging's technical support team and each unit's user; and c) Confirm completion of each update on the attached Device Reconciliation Form. d) For units that require physical return, quarantine and stop distribution. For units distributed, identify each affected customer, coordinate on-site access for collection, and arrange return shipment to Kent Imaging. Questions can be directed to [email protected]
Quantity in commerce: 77
Distribution: US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.
Product codes and lots: UDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2775-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2775-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code QJF

K242669Class IISnapshotGLO (KB100)Kent Imaging, Inc. / cleared 2025-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)