KENT IMAGING, INC. recalls SnapshotGLO Wound Imaging Device
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- SnapshotGLO Wound Imaging Device, Model KB100KB100AAUDI-DI B376KB1000
What the firm is doing
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
DistributionShow detailsHide
US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2775-2026
- FDA 510(k) clearance · K242669The device's official FDA premarket clearance record
- FDA device classification · QJFOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4550The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find KENT IMAGING, INC.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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