Class 2 Device Recall SnapshotGLO

• Date Initiated by Firm: June 30, 2026
• Date Posted: July 22, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2775-2026
• Recall Event ID: 99406
• 510(K)Number: K242669
• Product Classification: Autofluorescence imaging adjunct tool for wounds - Product Code QJF
• Product: SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
• Code Information: UDI-DI: B376KB1000, Software Revisions v4.2.0 and v4.1.3
• FEI Number: 3009771004
• Recalling Firm/ Manufacturer: KENT IMAGING, INC.; 1210 8 St Sw Suite 300; Calgary Canada
• Manufacturer 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.
• FDA Determined 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 customerservice@kentimaging.com 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 hitaloa@kentimaging.com
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QJF